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Development Resource Group

Get updates on all the job openings from Development Resource Group.

Category : Mechanical Designer
Job Type : Contract-to-Hire
Id : 7154
Region : Twin Cities

Seeking an Electrical Drafter who can create Autocad documents from descriptions and notes from engineers. Must have knowledge of wiring.

Primary responsibility would be CAD red line updates for a Engineering team.

3-5 years experience in a Mechanical/Electrical environment.


 

Posted: January 17, 2018, 9:37 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7215
Region : Twin Cities

Supplier Quality Engineer needed to support the change of existing product from current supplier to new supplier with manufacturing based overseas. This position will include all activities associated with Qualifying and approving the new supplier, Including: collaborating on Test Methods, Test Method Validations, Operational Qualifications, Installations Qualifications and Process Qualifications.

Position Responsibilities:

  • New Product Development activities including Process development
  • Material Review Board
  • Inspection Procedure creation and modification
  • Support product continuation by assuring the quality of the components used in the manufacturing floor, and working supplier/component quality related issues to resolution.
  • Review and approve changes to components for quality impact to materials and processes.
  • Participate in or lead materials problem solving, failure analysis, and process changes.
  • Qualify New Product Development finished devices and components and supplier changes to finished devices and components.
  • Participate in Supplier Management Review activities
  • Initiate and maintain appropriate corrective and preventive action per defined procedures

Position Requirements:

  • Bachelor’s degree
  • 1-5 years relevant experience


Posted: January 17, 2018, 6:31 am
Category : Technician - General
Job Type : Contract
Id : 7214
Region : Twin Cities

Seeking a Build Technician to test subassemblies, test leads and test extensions.

This person will interface with design engineers, technicians, and manufacturing engineers.

Must be able to work under a microscope, in a clean room and has small medical device assembly/building experience.



Posted: January 16, 2018, 11:09 am
Category : Reliability Engineer
Job Type : Contract
Id : 7212
Region : Twin Cities

Seeking a Reliability Engineer to provide design assurance engineering (DAE) support to new product development and sustaining activities for a Medical Device manufacturer. This individual must be well rounded with a good statistical background, hands on experience with equipment, testing and test method validation activities, root cause analysis, including experience supporting CAPA’s, and working knowledge of risk management to lead and participate in risk management planning, risk analysis (FMEA’s). Individual must be able to multitask and work within established schedule requirements, and work in close collaboration with Design, Component Suppliers, Manufacturing, and other Quality departments.

POSITION RESPONSIBILITIES:

  • Lead test method validation activities related to new or revised TM’s.
  • Lead and/or participate in FMEA/Risk Management activities.
  • Lead and/or participate in design verification and design validation for new products and modifications to existing products.
  • Serves as a technical resource for problem investigations to guide root cause analysis and corrective action development.
  • Work in a cross-functional, collaborative, team-based environment; work with multiple sites in various locations, time zones, and countries
  • Work under minimal supervision. Independently determine and develop approach to solutions.
  • Contribute to the completion of specific programs and projects.
  • Anticipate roadblocks; provide direction for navigating the quality system and supporting applications.
  • Lead and support corrective and preventive actions, as necessary.
  • Provide timely updates and presentations to as applicable for process improvements, design improvements, and root cause analysis.
  • Perform standards review, and documentation of evidence of conformity.
  • May provide guidance to lower level personnel.

POSITION REQUIREMENTS:

  • Bachelor’s degree in Engineering or technical discipline
  • 5+ years quality, reliability, or design assurance engineering experience
  • Working knowledge of Statistical Analysis tools: DOE, Gage R&R, Confidence and Tolerance intervals, ANOVA, Capability, Hypothesis testing
  • Experience leading risk management activities, including Risk Management planning, risk analysis techniques such as Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and hazard analysis
  • Working knowledge of reliability analyses and test methods, including establishing relevant test parameters and sample sizes
  • Working knowledge of design verification and design validation for new products and modifications to existing products
  • Knowledge of applicable ISO standards and FDA regulations
  • GMP, QSR, ISO 13485, ISO 14971 experience
  • Ability to effectively manage multiple competing priorities
  • Strong written and verbal communication skills
  • Good interpersonal and group leadership skills
  • Basic PC skills (MS Word, Excel, PowerPoint, MS Project, etc.)

PREFERRED QUALIFICATIONS:

  • Master's degree
  • 8+ years medical device or other regulated industry experience
  • Experience with medical devices, in particular cardiac surgery devices
  • Experience with reliability testing and analysis of medical devices
  • Understanding of clinical/technical applications of cardiovascular products and human anatomy
  • Certified Quality Engineer (CQE)
  • Certified Reliability Engineer (CRE)
  • Experience with ISO 5840, IEC 62366
  • Effective negotiation, collaboration and influencing skills


Posted: January 16, 2018, 9:17 am
Category : Mechanical Designer
Job Type : Contract
Id : 7213
Region : Twin Cities

Seeking a Senior Mechanical Design Engineer for the following:

  • Develop mechanical automation designs from customer specifications
  • Provide technical direction in a team-oriented work environment
  • Lead all design aspects for assigned projects in a team-oriented work environment
  • Develop and implement design standards
  • Perform or participate in internal project design reviews
  • Interface with customers on technical projects
  • Use analytical tools to assist in the design process
  • Interface with suppliers

Skills/Qualifications:

  • Experience with 3D CAD modeling packages - Solidworks and Unigraphics a plus
  • Ability to manage an automation design from the concept phase through modeling and detailing
  • Experience in a “systems” approach to automation design
  • Demonstrated ability to own and drive projects to completion
  • The drive to consistently deliver on commitments

Position Requirements:

  • BS or MS in Mechanical Engineering
  • 4 – 6 years of experience in automated design
  • Only those persons authorized to work permanently for any employer in the US will be considered


Posted: January 16, 2018, 9:12 am
Category : Reliability Engineer
Job Type : Contract
Id : 7211
Region : Twin Cities

Seeking a Reliability Engineer to provide design assurance engineering (DAE) support to new product development and sustaining activities for a Medical Device manufacturer. This individual must be well rounded with a good statistical background, hands on experience with equipment, testing and test method validation activities, root cause analysis, including experience supporting CAPA’s, and working knowledge of risk management to lead and participate in risk management planning, risk analysis (FMEA’s). Individual must be able to multitask and work within established schedule requirements, and work in close collaboration with Design, Component Suppliers, Manufacturing, and other Quality departments.

POSITION RESPONSIBILITIES:

  • Lead test method validation activities related to new or revised TM’s.
  • Lead and/or participate in FMEA/Risk Management activities.
  • Lead and/or participate in design verification and design validation for new products and modifications to existing products.
  • Serves as a technical resource for problem investigations to guide root cause analysis and corrective action development.
  • Work in a cross-functional, collaborative, team-based environment; work with multiple sites in various locations, time zones, and countries
  • Work under minimal supervision. Independently determine and develop approach to solutions.
  • Contribute to the completion of specific programs and projects.
  • Anticipate roadblocks; provide direction for navigating the quality system and supporting applications.
  • Lead and support corrective and preventive actions, as necessary.
  • Provide timely updates and presentations to as applicable for process improvements, design improvements, and root cause analysis.
  • Perform standards review, and documentation of evidence of conformity.
  • May provide guidance to lower level personnel.

POSITION REQUIREMENTS:

  • Bachelor’s degree in Engineering or technical discipline
  • 5+ years quality, reliability, or design assurance engineering experience
  • Working knowledge of Statistical Analysis tools: DOE, Gage R&R, Confidence and Tolerance intervals, ANOVA, Capability, Hypothesis testing
  • Experience leading risk management activities, including Risk Management planning, risk analysis techniques such as Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and hazard analysis
  • Working knowledge of reliability analyses and test methods, including establishing relevant test parameters and sample sizes
  • Working knowledge of design verification and design validation for new products and modifications to existing products
  • Knowledge of applicable ISO standards and FDA regulations
  • GMP, QSR, ISO 13485, ISO 14971 experience
  • Ability to effectively manage multiple competing priorities
  • Strong written and verbal communication skills
  • Good interpersonal and group leadership skills
  • Basic PC skills (MS Word, Excel, PowerPoint, MS Project, etc.)

PREFERRED QUALIFICATIONS:

  • Master's degree
  • 8+ years medical device or other regulated industry experience
  • Experience with medical devices, in particular cardiac surgery devices
  • Experience with reliability testing and analysis of medical devices
  • Understanding of clinical/technical applications of cardiovascular products and human anatomy
  • Certified Quality Engineer (CQE)
  • Certified Reliability Engineer (CRE)
  • Experience with ISO 5840, IEC 62366
  • Effective negotiation, collaboration and influencing skills


Posted: January 15, 2018, 10:55 am
Category : Electrical Engineer
Job Type : Contract-to-Hire
Id : 7210
Region : Twin Cities

We are seeking an Electrical Hardware Engineer with strong board-level hardware design and troubleshooting skills to execute on wireless product development activities for our clients in a professional engineering services setting. The candidate will develop wireless products across a variety of applications and technologies. The candidate must be able to operate in a matrix organization, working with project managers, system engineering, other design teams, and external clients and partners. Tactically, the candidate will be responsible for all aspects of hardware development – working with the project team to design, test, troubleshoot, document, certify, and release new products while meeting schedule, performance, and budget objectives.

Key Job Responsibilities:

  • Interact with Systems Engineering, external clients, and other functional teams to identify and distill product requirements into design specifications and test plans.
  • Develop requirements from product functionality, performance metrics, and client needs and drive architectural decisions.
  • Design, integrate, test, certify, and document board-level hardware design projects spanning a variety of applications and technologies.
  • Perform schematic entry and create detailed hardware specification documents.
  • Oversee hardware layout, design qualification, and manufacturing implementation.
  • Lead internal and client design reviews – generate formal written reports with feedback and recommendations and present findings to clients.
  • Drive feasibility and trade-off analyses to determine product or requirement feasibility and support product architecture definition.
  • Proactively leverage the available resources to minimize project expense when working with new technologies and responding to unforeseen issues.
  • Identify and control project risk associated with hardware development, working with project management and other team members to implement risk-reducing plans.
  • Drive process improvements, share industry best practices, and support continuous improvement of the Hardware Engineering team
  • Lead, mentor, and coach other engineers in the organization.

Qualifications and Requirements:

  • Bachelor of Science (BS Electrical Engineering preferred)Prefer 5+ years of related professional experience in an engineering role.
  • Experience working with microcontrollers and microprocessors and capable of performing tradeoff analyses to drive architectural decisions
  • Experience with digital logic, switching power supplies, high speed memory interfaces, op amp circuits, audio, and amplifiers.
  • Proficient with test equipment: oscilloscopes, logic analyzers, and multi-meters. RF equipment experience is a plus.
  • Experience with wireless certifications or regulatory testing (FCC, EN, or PTCRB). Cellular carrier approval experience is a plus.
  • Experience with schematic capture toolset and PCB layout tools.
  • Ability to manage available work time effectively, set and hold schedule commitments, and pro-actively identify and communicate project risks and setbacks.
  • Accountable – takes responsibility for decisions, actions and results
  • Open and candid communication skills; demonstrate inclusive behavior, ability to build trust and inspire others.
  • Leads change, personally adaptable, and able to perform well under pressure.

Other Desirable Skills:

  • Excellent written and verbal communication skills. Comfortable communicating with external clients to communicate technical status.
  • Experience in the electronic design services industry (e.g. contract design / consulting)
  • This position has minimal travel requirements (up to 10%); work is primarily performed in a collaborative office environment.
  • Simulation experience with PSpice.
  • Statistical analysis methodologies (six sigma, lean sigma, DFSS, DOE, etc.)


Posted: January 15, 2018, 9:02 am
Category : Electrical Engineer
Job Type : Contract
Id : 7208
Region : Twin Cities

The Electrical Engineer will support the Implantable Medical Device Released Product Engineer team. They will be responsible for electrical engineering design support for released products and associated instruments.
The primary areas of excellence for this position are implementation of product design and design specification improvements. The engineer will also review post market product performance and implement improvements to meet reliability, compliance, and cost reduction initiatives.
This position will develop technical solutions to problems that require ingenuity and creativity. Apply technical expertise and should have knowledge of other related disciplines such as manufacturing and process technologies. This Represents the design organization as the primary design contact for continuous improvement, CAPA, and returned product analysis initiatives.

POSITION REQUIREMENTS:

  • B.S. in engineering or appropriate technical discipline (Electrical Eng, Biomedical Eng. with electrical emphasis or equivalent).
  • Minimum of 1 year in a design, manufacturing or post-market product development support role, preferably in support of medical devices.
  • Knowledge of manufacturing, clinical, and regulatory requirements is helpful;
  • Experience in a manufacturing environment; cross-functional technical experience; industry knowledge.
  • Knowledge of engineering statistical tools/methods such as DOE, Monte Carlo, Minitab, ANOVA;
  • Experience using and FMEA and FTA methods is helpful


Posted: January 12, 2018, 1:11 pm
Category : Mechanical Designer
Job Type : Contract
Id : 7209
Region : Twin Cities

Seeking a Mechanical Engineer with Medical Device experience to provide post-market design support of implantable leads, catheters, and related accessories. The primary areas of excellence for this position are implementation of product design and design specification improvements. The mechanical design engineer will also review post market product performance and implement improvements to meet reliability, compliance, and cost reduction initiatives. This position will develop technical solutions to problems that require ingenuity and creativity, apply technical expertise and should have knowledge of other related disciplines such as manufacturing and process technologies. This role will represent the design organization as the primary design contact for continuous improvement, CAPA, and returned product analysis initiatives.

POSITION REQUIREMENTS:

  • B.S. in engineering or appropriate technical discipline (Mech Eng, Materials Science, Biomedical Eng. or equivalent)
  • Knowledge of manufacturing, clinical, and regulatory requirements
  • Experience in a manufacturing environment; cross-functional technical experience; industry knowledge.
  • Knowledge of engineering statistical tools/methods such as DOE, Monte Carlo, Minitab, ANOVA; Experience using and FMEA and FTA methods
  • Proficient with Pro/Engineer software or equivalent CAD software
  • Knowledge of lab practices, procedures, and tools/equipment.

PREFERRED SKILLS:

  • Minimum of 3 years in either a manufacturing or post-market product development support role, preferrably in support of implantable medical devices
  • Master's Degree in engineering or appropriate technical discipline (Mech. Eng, Materials Science, or equivalent)
  • Experience with CAPA (corrective and preventative action) and continuation projects in a medical device environment
  • Experience interfacing with physician customers and therapy consultants/sales
  • Proficient with GD&T tolerance and dimensioning methods and tolerance analysis
  • Proficient with DFSS principles (VOC, Transfer Functions, etc.) as they relate to designing robust products
  • DFLS or DFSS Green Belt certification


Posted: January 12, 2018, 1:10 pm
Category : Drafter
Job Type : Contract
Id : 7207
Region : Twin Cities

As a Design Technician/Drafter, you will apply Computer Aided Design (CAD) software, design/engineering methods and techniques in the design of mechanical and electrical components, assemblies and test fixtures. Develop solid models to capture design intent and for computational analysis to enable 1st pass success. Stay current on technology advancements in CAD which includes application software, materials, component selection, assembly design, design for manufacturing processes, design for serviceability, and design for reliability.

Day in the Life:

  • Solid modeling of objects (components, assemblies, test fixtures) to capture design intent
  • Create 2D drawings for components and assemblies
  • Create interface specifications
  • Create animations, renderings, and drawings to support other functions (e.g. manufacturing procedure support)
  • Provide services to enable proper data management
  • Partner with engineering to improve internal process and outcomes
  • Work directly with engineers on design iterations and adherence to company best practices
  • Apply Design for Reliability and Manufacturability (DRM) principles to ensure designs have high manufacturing capability and reliability

Minimum Requirements:

  • HS Diploma or GED
  • Practical experience applying SolidWorks and/or Creo to mechanical designs
  • Familiarity with ASME Y14 drafting, dimensioning, and tolerancing standards
  • Excellent communication skills
  • Good teamwork and interpersonal skills,
  • Strong mechanical aptitude
  • Strong work ethic and efficiency; a self-starter
  • Ability to travel OUS 10-25%

Nice to Have:

  • Associate (2 year) Mechanical Design Technical degree with 10 years of design experience
  • Familiarity with design of: gas management systems, electrical cables, wire harnesses, sheet metal parts and assemblies, machined components, injection molded components, thermoformed components, and electronics enclosures
  • Familiarity with IEC 60601-1
  • Skilled in day to day usage of PDM (Product Data Management) systems/electronic vaults to manage CAD models/drawings
  • Familiarity with executing tolerance analyses, including use of software applications such as Minitab and CETOL
  • Forethought to help identify opportunities in the design environments to increase productivity, manufacturability, reliability
  • Ability to improve design environment standard work and best practices and drive implementation internally (e.g. support development of internal hardware library systems)


Posted: January 12, 2018, 6:53 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7206
Region : Twin Cities

Seeking an experienced Supplier Quality Engineer to actively work with suppliers in identification resolution of quality issues and support completion of various levels of qualification. This position will be a member in the Supplier Quality organization with Site Leadership

POSITION RESPONSIBILITIES:

  • Lead the audit/assessment of current or future suppliers ensuring they are compliant with associated Company policies and GMP/ISO requirements from SME perspective.
  • Assist in developing Supplier Quality Agreements with key suppliers including coordinating negotiations and processing through cross functional approval at Company (Including Legal, Quality and SourcingSupport projects/programs associated with component(s) qualification (Independent reviewer and approver)
  • Drive sub-tier supplier requirements and monitoring as defined in the risk management assessments.
  • Review Drawings configuration, mechanical interfaces/operation and material selection to determine the appropriate inspection requirements, methods and sample sizes
  • Review/Approve test plans and reports (qualification, validation) for assigned change and new tool development activities.
  • Develop a strong relationship with supplier as related to quality system issues and qualifications related to injection molding
  • Develop and maintain strong working relationship with functinal groups (R&D, ME, Quality Operations, Supply Chain and Regulatory)
  • NCMR Process ownership including all disposition/mitigation/corrective action activities.
  • Assure the resolution of all issues raised during processing and inspection/testing with supplier.
  • Provide support to sustaining engineering.
  • Initiate quality improvement initiatives at key suppliers. Efforts may include supplier escape reduction to implementation of Supplier Owned Quality and/or Certification Programs.
  • Provide input into the design, reliability, and manufacturability of new products and coordinate activities within our supplier base. Work closely with component engineers to ensure supplier practices are used across the business.
  • Provide statistical support by the creation of supplier related metrics for the purposes of tracking processing performance and identifying opportunities for supplier improvements.
  • Provide support to junior staff resources to prioritize and and execute tasks/responisbilitie.
  • Support/participate in the CAPA process for resolution of issues and corrective actions.
  • Work with the Quality Management System and maintain compliance with corporate policies, FDA’s QSRs, ISO 9001, IVDD, AIMDD, CMDCAS, CMDR, ISO 13485, MDD/EN46001 and other quality requirements, regulations and guidelines.

BASIC QUALIFICATIONS:

  • BS/BA degree in engineering or science
  • Minimum of 2 years in Medical Device Industry
  • Minimum 2 years in Supplier Quality
  • 5 years related engineering experience
  • Lead Supplier Auditor experience (developing audit plans and conducting audits)
  • Use and understanding of Statistical Tools (Design of Experiments, Measurement System Analysis, Process Capability and Statistical Process Control)
  • Knowledgeable of the processes characterization studies and creation of qualification protocols and reports (including structured DOE evaluation and/or IQ/OQ/PQ/PV documentation)
  • Understanding of Geometric Dimesional Tolerancing (GDT) and application for inpsection setup and tolerancing allowances of molded components
  • Oral, Presentation and Written communication skills
  • Ability to work in a team/partnership environment
  • Computer Skills (Microsoft- Word, Excel, Project, PowerPoint)


Posted: January 11, 2018, 2:08 pm
Category : Technicians
Job Type : Contract
Id : 7205
Region : Twin Cities

Seeking an Electrical Design Technician to develop and execute electrical tests to characterize or verify the functionality of hardware systems. This position works closely with engineers to design and redesign devices, fixtures, test systems and components. Also, evaluates preliminary designs for compliance with specified requirements.

POSITION RESPONSIBILITIES:

  • Performs a variety of technical duties including design, assemble, and test unique hardware and software test systems with minimal engineering input.
  • Perform circuit characterization and design verification tests, analyzing and reporting results using spreadsheets, tables and graphs.
  • Hardware circuit performance analysis and troubleshooting on analog and digital circuits
  • Contributes to design documentation that is required by Quality Systems and recommends changes as needed
  • Work closely with engineering and test partners, participating in design reviews, troubleshooting strategy, and issue resolution.

BASIC QUALIFICATIONS:

  • Must be able to read electrical schematics and have an understanding of analog and digital circuits and be able to operate test equipment such as Oscilloscopes, logic analyzer, counters, etc.
  • 2+ years of LabVIEW programming experience with the ability to create automated test setups
  • Able to collect test data utilizing automated and manual test techniques
  • Desire and ability to work effectively and efficiently in a team environment. Ability to multi-task in a fast-paced environment
  • Good prioritization and verbal/written skills.
  • Good working relationship with peers; able to create a positive work environment.

POSITION REQUIREMENTS:

  • Two-year electronics degree or equivalent.
  • 2 years in an electrical test environment
  • Medical device design or experience in other highly regulated environments (Military, Government, etc.)
  • Use of high end test equipment and or custom test setups to perform evaluation, characterization, or verification of electric designs
  • Ability to working closely with other technicians and design engineers to evaluate new electrical designs and execute verification tests by collecting data and providing detailed reports after test completion

PREFERRED SKILLS:

  • Research clinical and market released systems
  • Animal and human clinical studies
  • Electro-mechanical test experience
  • Test development and operation using LabVIEW
  • RF test, MRI test, test systems simulation, test instrument build
  • Programming experience using LabVIEW, C++ or C#
  • Experience using IEEE488 instrumentation



Posted: January 10, 2018, 1:10 pm
Category : Technical Writer
Job Type : Contract
Id : 7204
Region : Twin Cities

Seeking a Technical Writer to be responsible for providing support to our engineering team, documenting electrical and mechanical designs, capture design requirements and specifications, and manage the bill of materials in a PLM system using ECO processes.

Position Responsibilities

  • Be part of a global engineering team to strive for functional excellence in all aspects of daily work.
  • Manage requirements, specifications, and test documents in ALM (Application Lifecycle Management) system
  • Release components parts and specs and structure Bills of Materials using Change Notices and Engineering Change Orders in a PLM (Product Lifecycle Management) system.
  • Develop and Maintain documentation using Microsoft Office and release in document control system
  • Collect technical documentation from engineers and coalesce into master documentation architecture
  • Ability to navigate and follow quality system requirements along with following good documentation practices (GDP)

Basic Qualifications

  • 5+ years of job-related experience

Preferred Qualifications

  • Experience in a regulated, documentation intense industry (e.g. Medical Devices, Aerospace, etc.)
  • Experience with PLM systems (e.g. Windchill, Agile, Enovia, etc.) including execution and management of Engineering Change Requests and Engineering Change Orders.
  • Experience with ALM systems (e.g. Cognition Cockpit, Jama, Doors, Codebeamer, Foundation Server, etc.) and/or database tools (e.g. MS Access, SQL, etc.)
  • Expertise in Microsoft Office
  • General understanding of electrical, mechanical, and software design processes and concepts
  • English or journalism degree from an accredited institution


Posted: January 10, 2018, 9:06 am
Category : Management/Operations
Job Type : Contract
Id : 7203
Region : Twin Cities

Seeking a Program Manager for a new product introduction project and to provide leadership to a cross functional project team to drive successful development and commercialization of new products. This position is responsible for the development/qualification of sourced components/finished goods.

POSITION RESPONSIBILITIES:

  • Lead cross functional teams through the product development process to ensure successful completion of development projects and business goals.
  • Responsible for developing, communicating, and documenting project strategies and plans including operations budget and detailed schedule creation and maintenance
  • Ensure the quality policy/system is planned, understood, implemented and maintained.
  • Ensure Operations aspects of Quality System Compliance, Design History File, and Regulatory Submissions documentation
  • Lead the supply chain schedule risk burn down
  • Champion sourcing strategy for program
  • Define and meet cost objectives for the sourced items.
  • Ensure Design for Reliability and Manufacturing (DRM) is consistently and rigorously applied

BASIC QUALIFICATIONS:

  • Bachelors degree in Science, Engineering and 7+ years of relevant experience in the in one or more of the following functional areas, including product development, manufacturing and operations
  • Masters degree and 5+ years or relevant experience in one or more of the following functional areas, including product development, manufacturing, and operations

PREFERRED QUALIFICATIONS:

  • Proven Program Management Experience leading cross functional teams in the commercialization of new products
  • Highly developed skill set in project leadership practices including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes
  • Excellent cross functional influence skills
  • Excellent downward, lateral, and upward communication skills
  • Experience in Medical devices commercialization activities
  • Strong financial planning and analysis skills
  • Ability to motivate and lead diverse group of individuals
  • Strong verbal and written communication skills
  • Negotiations and Business development skills
  • DRM or Six Sigma Green Belt or Black Belt
  • Self-Driven and results oriented


Posted: January 10, 2018, 7:01 am
Category : Project Manager
Job Type : Contract
Id : 7202
Region : Twin Cities

Seeking a Project Manager to lead and ensure a successful execution and closure of assigned projects. The successful candidate will manage scope, schedule and budget of assigned projects. Be the single point of contact for all assigned customers projects and be Proactive Project Risk Mitigation.

Key Responsibilities:

  • Single point of contact for assigned projects from Order Launch through shipment.
  • Facilitate review of customer specifications and quotes such that the scope of work is defined.
  • Estimating, quoting, and documenting change(s) in scope to customer.
  • Direct communication to align and reconcile project expectations with deliverables.
  • Collaborate in assembling project financial plan, monitor the plan and drive for corrective action when plan is in jeopardy.

Additional Responsibilities:

  • Work with customers to correct measurable, significant lapses in plan.
  • Provide ongoing support after shipment as necessary, until customer is completely satisfied.
  • Arrange and facilitate all customer visits during duration of project.
  • Obtaining from customer all that is needed for our completion of project: specifications, test material,
  • floor plan sign offs, payments, etc.
  • Coordinates project work plan for successful project completion.

MINIMUM JOB REQUIREMENTS:

  • Bachelor’s degree in related field or equivalent experience
  • Experience in a fast paced, engineered to order, manufacturing environment
  • Five years of experience in a project management position.
  • Demonstrated technical competency with product line
  • Highly organized and good at managing details
  • Exceptional presentation skills
  • Aptitude to deal directly with customers effectively in high pressure situations, not conflict-adverse
  • Proactive on follow-up, not letting issues linger
  • Exceptional written and verbal communications skills
  • Proven ability to plan
  • Good negotiator (searches for “win-win” solutions)
  • PMP or similar certificate desirable


Posted: January 9, 2018, 11:49 am
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7201
Region : Twin Cities

Seeking a Build Technician to work in building Developmental Octave Lead and Extension units. This candidate will be building test subassemblies, test leads and test extensions. This position will interface with design engineers, technicians and manufacturing engineers and will be trained on various assembly processes.

Position Requirements:

  • Small medical device assembly/building experience.
  • Ability to use a microscope when building
  • Experience working in a Cleanroom environment


Posted: January 9, 2018, 8:16 am
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7200
Region : Twin Cities

Seeking a Mid-level technician to provide analysis and repair of external Medical Devices in the Service Center to GMP and ISO requirements. This individual will perform assigned tasks & routine duties using standard practices and work instructions in the area under limited supervision. Technician will use electronic training and knowledge of repair techniques using standard test equipment and hand tools. Position requires considerable level of knowledge and judgment in determining work methods, performing tasks / tests and recording data.

MAIN JOB DUTIES / RESPONSIBILITIES:

  • Perform job functions under limited supervision in Service Center while receiving some input from senior technician’s, may require travel to off-site locations.
  • Perform test and repair using the instrument manual and appropriate work instruction.
  • Analyze, troubleshoot, and repair instrument device on a routine basis.
  • Document analysis, repair, and parts utilized to satisfy traceability and regulatory req.
  • May have full responsibilities for minor projects and assist in project planning & budgeting.
  • Use and recommend revision of maintenance manuals and work instructions as necessary.
  • Work overtime when necessary to support high priority requests or meet metric goals.

POSITION REQUIREMENTS:

  • Minimum two year technical diploma in
  • Strong math & physics background
  • 4 to 5 years’ related experience
  • Electronics or Military equivalent training
  • Knowledge of Microsoft Office Apps
  • 4 to 5 years’ experience Word, Excel, Access, Power Point
  • Familiar with FDA 21 CFR Part 820
  • Knowledge of ISO 13485

REQUIRED SKILLS:

  • Basic Electronic Theory & understanding
  • Organized, efficient, process orientated
  • Understand general electronic troubleshooting
  • Interpersonal / communication skills
  • General understanding of Documentation
  • Self-motivated / Team player
  • Practices Strong work ethic / Tactful
  • Solder skills a plus
  • Exercises independent judgment


Posted: January 8, 2018, 9:19 am
Category : Mechanical Designer
Job Type : Contract
Id : 7199
Region : Twin Cities

Seeking a Mechanical Design Engineer to support the development of existing and new implantable Medical Device test systems designs with responsibility for test system design initiation through product design verification testing; specifically:

  • Equipment Specifications, Design and Build
  • Installation Qualification protocols, testing, and reports
  • Operational Qualification protocols, testing, and reports
  • Software Validation protocols, testing, and reports
  • Documented Test Methods
  • Test Method Validation Protocols, testing and reports (including the planning and execution of GR&Rs)

Education Required:

  • B.S. in Mechanical Engineering or related technical discipline (e.g. Biomedical Engineering, Materials Science, or equivalent)
  • 0-3 years experience


Posted: January 8, 2018, 9:08 am
Category : Software Test Engineer
Job Type : Contract
Id : 7198
Region : Twin Cities

We are seeking a Sensor Performance and Software Tester for our sensor products division. This job involves testing the measurement performance and functionality of the sensors we produce as well as testing new features and functionality of supporting inspection software.

 

The ideal candidate will have the following skills:

  • An undergraduate degree in a technology related field
  • A good understanding of the software development process
  • Good written and verbal communication skills
  • Enthusiasm for testing and the ability to identify techniques to streamline testing
  • Ability to work as part of a scrum team as well as being self-motivated and self-directed
  • Eagerness to learn about new technologies and tools

Other useful skills for the job:

  • Experience with software development using C++ and/or C#
  • An understanding of basic statistics, and linear regression
  • Experience with statistics tools such as Minitab, Matlab and Excel
  • Experience with Design of Experiments
  • Experience with regression testing
  • Experience with automated testing tools

A background in mathematics and/or engineering



Posted: January 8, 2018, 8:44 am
Category : Software Engineer
Job Type : Contract
Id : 7197
Region : Twin Cities

Seeking a highly motivated, highly skilled and committed Software Engineer to develop and test embedded software (firmware) for Neurostimulators and Infusion (drug delivery) devices.

This position involves the verification test design, implementation, execution and documentation to support software of the implantable devices. This position requires the understanding and following of regulations, procedures and guidelines for software developed in a medical device. A successful candidate is self-motivated and is able to work in a team environment. The successful candidate is a continuous learner and strives for continuous improvement.

POSITION RESPONSIBILITIES:

  • Specifies, designs, documents and verifies embedded SW for medical devices in a regulated environment using standard SW engineering tools and methods.
  • Develops and implements verification designs based on requirements and specifications.
  • Designs tests for unit, integration and verification testing based on design specifications.
  • Designs, debugs and tests own software and software developed by others.
  • Prepares and maintains formal design documentation.
  • Prepares plan and time estimates for own work under the minimal guidance of a more experienced engineer.
  • Participates in technical reviews and leads the review for their own work.
  • Follows company policies and procedures.
  • Provides ongoing status updates.
  • Identifies opportunities for productivity and quality improvements
  • Understand and follow the Neuro Quality System Policies
  • Specifies, designs, documents and verifies embedded SW for medical devices in a regulated environment using standard SW engineering tools and methods
  • Develops and implements verification designs based on requirements and specifications
  • Designs, debugs and tests own software and software developed by others
  • Provides ongoing status updates
  • Identifies opportunities for productivity and quality improvements
  • Implement (using TCL) test scripts and execute the test scripts in simulation
  • Analyze data and author test reports
  • Ensure personal understanding of all quality policy/system items that are personally applicable.
  • Follow all work/quality procedures to ensure quality system compliance and high quality work.


Posted: January 5, 2018, 1:51 pm
Category : Software Engineering
Job Type : Contract
Id : 7196
Region : Twin Cities

Seeking a Software Engineer to perform verification test activities Medical Device Software products on our clinician and patient care management system. Develop tests for web based, mobile, and custom medical device applications by designing, implementing, and executing tests for the verification of software requirements.

The ideal candidate is a software engineer with object oriented programming experience capable of analyzing software requirements, defining extensible test scenarios, and developing automated tests (in C#) to verify web based software in the medical device industry.

POSITION RESPONSIBILITIES:

  • Provide solutions to a wide range of problems that are imaginative, thorough, practical, and consistent with organizational objectives.
  • Estimate effort and duration of tasks and develop and execute plans and strategies to complete the work on time.
  • Analyze, understand, and review product requirements.
  • Participate in the technical reviews of software requirements.
  • Interface with product owners and software developers to clarify expected software behavior.
  • Design and execute tests using automated test tools, as well as manual test development process, for the verification of software requirements.
  • Establish and maintain traceability from software requirements to verification test design and implementation.
  • Participate in the technical review of verification tests and results.
  • Assist scrum team with debugging and solving issues discovered during test.
  • Operate electronic testing equipment.
  • Prepare, review, submit, and maintain project/product documentation.

BASIC QUALIFICATIONS:

  • B.S. in Engineering or related field with 2+ years of experience.
  • M.S. in Engineering or related field with 0+ years of experience.
  • Proficiency with one or more of the following programming languages: C#, .NET, HTML, Java, JavaScript, C++, Python.
  • Experience analyzing requirements and defining test cases.
  • Excellent problem solving, analytical skills and technical troubleshooting skills.

DESIRED/PREFERRED QUALIFICATIONS

  • Experience developing automated tests.
  • Experience using SpecFlow, Cucumber, Coded UI.
  • Understanding of both Agile and Waterfall software development methods.
  • Understanding of one or more of the following operating systems: Windows, Android and iOS.
  • Understanding of MS Server technologies (MS SQL, XML/XSLT).
  • Quality focus, willingness to learn, versatility and adaptability.
  • Good organizational skills and strong written and verbal communication.
  • Ability to work on cross-functional project teams comprised of software verification and development engineers, system engineers, human factor engineers and quality engineers.
  • Understanding of one or more of the following tools: Visual Studio, Team Foundation Server, Microsoft Test Manager.
  • Design/test experience working within a regulated environment.
  • Experience working within a regulated environment.
  • Experience with software version control tools.



Posted: January 5, 2018, 10:52 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7195
Region : Twin Cities

Seeking a Manufacturing Engineer with Medical Device experience for the following:

  • Design of Experiments (DOE) and Statistical Process Control (SPC)
  • Determines manufacturing operation requirements and process parameters
  • Develops advanced Laser and/or resistance welding manufacturing systems and processes
  • Develops plans to evaluate process repeatability and stability
  • Participates in procedure writing and review
  • Performs process and equipment validations (e.g. Software Installation and Validation; Installation, Operational, and Performance qualifications)
  • Provides technical support to other engineers
  • Supports manufacturing, development, and implementation processes
  • Utilizes FMEA within process development
  • Generates documentation for engineering protocols and reports
  • Writes engineering and manufacturing specifications

Job Requirements:

  • Bachelors Degree in related field
  • 2-5 years experience

Keywords: Laser Resistance Weld Installation Qualification IQ, OQ, PQ Beam profiling Temporal profiling Equipment validation, acceptance Equipment specification Tophat, Gaussian Medical device Protocol Trumpf, IPG, LASAG Spiricon beam analyzer Process development Tool, fixture design Software validation Programming Process documentation pFMEA vision application development



Posted: January 3, 2018, 12:19 pm
Category : Mechanical Designer
Job Type : Contract
Id : 7194
Region : Twin Cities

Seeking a Mechanical Design Engineer to provide support for the product development of medical devices and instrumentation.

Position Responsibilities

  • Conceptualize, design, simulate, and verify limited portions (component to sub-assembly level) of a mechanical design for medical devices or instrumentation in a regulated environment using standard mechanical engineering tools and methods.
  • Design, simulate and test own mechanical designs and assist with designs developed by others.
  • Design mechanical tooling, assembly fixtures, processes and tests for prototypes and verification testing, under the guidance of a more experienced engineer.
  • Prepare, document, and maintain formal documentation/reports under the guidance of a more experienced engineer. Prepare all documentation in a manner consistent with department protocol.
  • Assist in assessing mechanical aspects of product, process, or material performance against established standards or specifications. Identify negative trends or failing conditions.
  • Work is closely supervised by senior engineer and follows specific, detailed instruction.
  • Develop and implement designs based on requirements specifications, under the guidance of a more experienced engineer.
  • Participate in technical reviews.
  • Provide ongoing status updates.
  • Assess design of limited scope and complexity for manufacturability cost

Minimum Education:

  • 3 years for an active student in a Mechanical or Biomedical Engineering Program.

Preferred Requirements:

  • B.S in Mechanical Engineering or related field with 0-1 year of experience.
  • Limited use and/or application of technical principles, theories, and concepts.


Posted: January 3, 2018, 9:06 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7193
Region : Twin Cities

Looking for motivated, highly accountable, and results-oriented Manufacturing Engineer to develop manufacturing processes for implantable medical components. Must have good mechanical aptitude and an individual who has experience in designing production tooling and fixturing; experience with drafting software itself not required. Specific deliverables include tool inspection reports, environmental health & safety assessments, process characterization, test method validation, pFMEA, IQ, OQ, PQ. Must have excellent oral and written communication skills and have experience generating high-quality documentation for FDA-regulated industry. Prior experience with ceramics, furnace applications, vacuum systems or physical deposition would be beneficial but not required.



Posted: January 3, 2018, 7:26 am
Category : Quality/Regulatory
Job Type : Contract
Id : 7192
Region : Twin Cities

Seeking a Quality / Test Method Validation Engineer to work on a cross functional team to conduct test method validations for a medical device transition project.

Position Responsibilities:

  • Development of test methods for both standard measurement equipment and product specific methods
  • Carrying out Gauge R&R and Attribute Agreement Analysis studies
  • Utilize statistical evaluation techniques to evaluate test data.
  • Writing protocols & technical reports
  • Review and approve test requests and studies as appropriate

Basic Qualifications:

  • Bachelor's degree in Science or Engineering discipline
  • 2-5 years of experience in the medical device industry or highly regulated industry

Preferred Qualifications:

  • Working knowledge of Minitab
  • Knowledge in developing test methods
  • Experience in writing test method protocols and validation
  • Experience in technical writing reports
  • Basic understanding and familiarity on test setup
  • Strong communication skills, both oral and written
  • Ability to work independently with minimal supervision


Posted: January 3, 2018, 7:22 am
Category : Electrical Engineer
Job Type : Contract
Id : 7191
Region : Twin Cities

Looking for a Senior Level Electrical Engineer to join our R&D Organization to design and develop new and modifications to AF Ablation Systems. The Senior Electrical Engineer will also be responsible for designing automated test systems or subsystems for testing the ablation systems.

Areas of responsibilities will include electrical system design, design requirements, test requirements and test procedures, PC-based simulation and data acquisition. Candidates must be able to translate design inputs into electrical options and concepts, write detailed electrical specifications, generate and review design documentation, test specifications and test reports in compliance with design control procedures used within the medical device industry. Candidates must also be willing to work in a fast paced, multi-tasking, team environment.

POSITION RESPONSIBILITIES

  • The candidate must have the ability to work well with a variety of individuals ranging from the various engineering disciplines (mechanical, electrical, and software) to marketing, clinical, reliability, regulatory and operations.
  • Bring clarity and focus to the early stages of hardware development; ensuring design inputs are translated into hardware/system options. It requires knowledge regarding the integration of features into the early stages of a project when many aspects of the feature set are not yet well defined
  • Review the designs of other engineers
  • Support Manufacturing in troubleshooting operations involving medical devices through assembly and test
  • Evaluate and select components, generate component specifications, as well as functional and test specifications
  • Provide technical assistance to other functional departments such as Quality, Reliability, and Manufacturing
  • Work independently, in consultation with Engineering Management
  • Ability to manage and provide day-to-day direction to Electrical Engineers and Technicians

BASIC QUALIFICATIONS

  • BS Electrical Engineering
  • Minimum 6+ years experience in digital, analog circuit design
  • Strong knowledge of schematic design and layout using CAD tools for PCB design such as OrCAD
  • Strong knowledge of formal PCBA documentation (schematics, PCB fabrication drawing, PCB assembly)
  • Strong experience in technical specification and report writing
  • Must be able to review the work of other engineers
  • Must be able to work with minimal supervision
  • Mastery of basic laboratory instruments and tools (e.g. DMM, oscilloscope, logic analyzer, spectrum analyzer)
  • Ability to work in a team environment; strong collaboration skills
  • Effective verbal and written communication

PREFERRED QUALIFICATIONS

  • MS Electrical Engineering
  • 5 or more years in one or more of the following: RF ablation generator design, medical device design, embedded microcontroller/microprocessor system design
  • Strong knowledge of RF circuit design
  • Specific knowledge of Domestic and International standards for Ablation Generators
  • Knowledge of engineering and manufacturing test equipment design and LabView is a plus
  • Knowledge of the application of DSPs is a plus
  • Experience working with vendors and contract manufacturers for PCB fabrication and assembly is a plus
  • Experience writing embedded firmware in assembly and/or C/C++ is a plus
  • Experience with SolidWorks is a plus


Posted: January 3, 2018, 6:38 am
Category : Software Test Engineer
Job Type : Contract
Id : 7190
Region : Twin Cities

Seeking a Software Test Engineer to develop automated testing for a Java-based desktop application. The test development work will involve writing Java code using the TestFx library, writing associated test documentation, following development and validation procedures, and participating in team meetings and code reviews. One to two years in testing and or software development desired. The position requires a high degree of independence and the individual can work remotely.



Posted: January 2, 2018, 8:55 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7189
Region : Twin Cities

Seeking a Manufacturing Engineer to provide engineering support to the manufacturing processes, by troubleshooting equipment downtime, identifying and implementing yield improvement activities, and performing investigation, disposition and corrective action for production issues.

 

Position Responsibilities:

  • Production Support and Trouble Shooting - Provide engineering support to manufacturing operations.
  • Ensure no negative impact on customer service and minimize downtime.
  • Perform investigation, disposition and corrective action for production issues through the quality system procedures (NCMR & CAPA).
  • With supervisory guidance, implements process and product improvements.
  • Determines specific requirements of manufacturing operation in order to specify equipment, fixturing and process parameters.
  • Continuous improvement and cost analysis.
  • Deploy Lean 6 Sigma methodology to identify, evaluate and implement opportunities for improvement in manufacturing processes.
  • Support plans to evaluate process repeatability and stability through equipment qualification and process validation.
  • In partnership with Finance, perform detailed cost analysis of manufacturing changes.
  • Demonstrate strong problem solving, project management, change management, analytical, and leadership skills.
  • Identification of cost reduction opportunities and perform assessment based on impact and effort for prioritization.
  • Communicate progress, status, and issues to upper management

 

Basic Qualifications:

  • Bachelor of Science in Engineering or related Technical/Scientific field of study
  • Minimum 2 years engineering experience
  • GMP, ISO and MDD requirements
  • Experience in Six Sigma methodology
  • Experience with problem solving using analytic s such as DMAIC/A3
  • Experience handling multiple tasks concurrently
  • Experience interpreting mechanical drawings
  • Knowledge of quality systems

 

Skills/Competencies:

  • Excellent Verbal and Written communications
  • Excellent data analysis skills, and proficient in the use of statistical tools in problem solving
  • Ability to solve complex problems.
  • Analytical and interpersonal skills
  • Critical thinking and problem solving
  • Computer skills such as Word and Excel
  • Basic Statistical skills

 

Preferred Qualifications:

  • Green Belt Certification (Internal or ASQ)
  • Experience with Medical Device Regulation ISO 13485
  • Experience in medical product manufacturing / assembly operations
  • Excellent data analysis skills and proficient in the use of statistical tools in problem solving

 

Posted: December 28, 2017, 9:59 am
Category : Packaging Engineer
Job Type : Contract
Id : 7188
Region : Twin Cities

Seeking a Labeling Specialist to be responsible for supporting the development of medical device package labeling.  This candidate will work with project Packaging Engineers to create and release labeling components interfacing with product development teams, manufacturing sites, regulatory and reliability engineers.

 

Position Responsibilities:

  • Creates or supports development of various required labeling components, including labeling design input requirements (DIR), component specifications, template designs and final label image specifications
  • Develops plan, manages and monitors timelines and process of new and revised labeling ensuring all deadlines are met
  • Reviews, and releases labeling for package labels, cartons and other related materials ensuring that they meet all documented design inputs
  • Understands labeling system requirements and is comfortable designing templates and troubleshooting the functionality of existing templates
  • Identifies potential improvements to the labeling development processes, systems, tools and/or policies
  • Coordinates the translations of package labeling through internal or external sources
  • Works with labeling system database(s) related to development of required label information

 

Basic Qualifications:

  • BA or BS Degree in Packaging
  • Minimum of 2 years of experience in labeling, package engineering, publishing or relevant industry
  • Comfortable learning and using new computer systems and programs
  • Highly detail oriented
  • Experience working in business systems including Excel and other Microsoft Office programs
  • Experience working with global teams
  • Experience using/developing systems to compile and relay information
  • Experience with system troubleshooting

 

Preferred Qualifications:

  • Previous database driven labeling system experience (Prisym 360, Transform) in a regulated industry
  • Previous Package labeling experience
  • Some basic programming skills, understands networks and servers
  • Knowledge of US and international medical device regulations and standards, especially those related to labeling
  • Experience in proofreading/editing
  • Strong problem solving/ troubleshooting skills related to systems


Posted: December 21, 2017, 2:50 pm
Category : Software Engineer
Job Type : Contract
Id : 7187
Region : Twin Cities

Seeking an experience Software Engineer to develop a database application for capturing key engineering information during medical device development.

Develop Windows-based user interface that allows users to add, maintain and delete data in a SQL Server database. User interface will also require the development of reports and/or data dumps to meet user needs. Also, must develop the test cases/plans to test the application to ensure it can be validated for its intended use. Execute test cases/plans to validate the application. All activities will be executed under control of Subversion for configuration management and Polarion for issue and work item tracking.

 

Required experience:

  • Microsoft .Net
  • C++
  • C#
  • C programming
  • Visual Studio
  • Microsoft SQL Server
  • SQL 

Preferred experience:

  • Experience in a Regulated development environment
  • Experience with software development process: design, test, release, and maintenance 


Posted: December 20, 2017, 2:39 pm
Category : Software Engineer
Job Type : Contract
Id : 7186
Region : Twin Cities

Seeking a Software Engineer to perform verification test activities Medical Device Software products on our clinician and patient care management system. Develop tests for web based, mobile, and custom medical device applications by designing, implementing, and executing tests for the verification of software requirements.

The ideal candidate is a software engineer with object oriented programming experience capable of analyzing software requirements, defining extensible test scenarios, and developing automated tests (in C#) to verify web based software in the medical device industry.

POSITION RESPONSIBILITIES:

  • Provide solutions to a wide range of problems that are imaginative, thorough, practical, and consistent with organizational objectives.
  • Estimate effort and duration of tasks and develop and execute plans and strategies to complete the work on time.
  • Analyze, understand, and review product requirements.
  • Participate in the technical reviews of software requirements.
  • Interface with product owners and software developers to clarify expected software behavior.
  • Design and execute tests using automated test tools, as well as manual test development process, for the verification of software requirements.
  • Establish and maintain traceability from software requirements to verification test design and implementation.
  • Participate in the technical review of verification tests and results.
  • Assist scrum team with debugging and solving issues discovered during test.
  • Operate electronic testing equipment.
  • Prepare, review, submit, and maintain project/product documentation.

BASIC QUALIFICATIONS:

  • B.S. in Engineering or related field with 2+ years of experience.
  • M.S. in Engineering or related field with 0+ years of experience.
  • Proficiency with one or more of the following programming languages: C#, .NET, HTML, Java, JavaScript, C++, Python.
  • Experience analyzing requirements and defining test cases.
  • Excellent problem solving, analytical skills and technical troubleshooting skills.

PREFERRED QUALIFICATIONS

  • Experience developing automated tests.
  • Experience using SpecFlow, Cucumber, Coded UI.
  • Understanding of both Agile and Waterfall software development methods.
  • Understanding of one or more of the following operating systems: Windows, Android and iOS.
  • Understanding of MS Server technologies (MS SQL, XML/XSLT).
  • Quality focus, willingness to learn, versatility and adaptability.
  • Good organizational skills and strong written and verbal communication.
  • Ability to work on cross-functional project teams comprised of software verification and development engineers, system engineers, human factor engineers and quality engineers.
  • Understanding of one or more of the following tools: Visual Studio, Team Foundation Server, Microsoft Test Manager.
  • Design/test experience working within a regulated environment.
  • Experience working within a regulated environment.
  • Experience with software version control tools.


Posted: December 20, 2017, 9:16 am
Category : Software Engineer
Job Type : Contract
Id : 7185
Region : Twin Cities

Seeking a Software Engineer to work with various software technologies in application software, mobile software, BT/BLE communication software, and interfacing with embedded software for management and control of implantable medical devices. Looking for a proactive, self-starting, strong software development engineer to build and maintain the next generation of medical instrument software. The individual will operate in all phases and contribute to all activities of the software development process

POSITION RESPONSIBILITIES:

  • Design, implement, test, debug and document integration solutions and enhance existing components to ensure that software meets the business needs, while in compliance with applicable regulations and processes.
  • Conduct design and code reviews to ensure code developed meets or exceeds coding best practices guidelines, unit testing, security, and scalability and maintainability guidelines.
  • Contribute to the design and architecture to enable secure, scalable, and maintainable software and clearly articulate the implications of design/architectural decisions, issues and plans to technology leadership.
  • Collaborate on the design with other team members and product owners, both inside and outside of the team.
  • Demonstrate ownership of software feature/module and drive development of the feature/module through SDLC.
  • Contribute and apply advanced technical principles, theories, and concepts to solve complex technical problems.
  • Provide hands-on leadership, coaching, mentoring, and software engineering best practices to junior software engineers.
  • Develop reusable patterns and encourage innovation that will increase team velocity.

BASIC QUALIFICATIONS:

  • B.S./B.A.in Computer Engineering/Science and 4+ years of experience (or M.S. and 2+ years)

SPECIALIZED KNOWLEDGE REQUIRED

  • Strong programming skills in C#
  • Experience with iOS or Android development
  • Experience with both iOS and Android development
  • Objective-C
  • Xamarin
  • Bluetooth or BLE experience
  • Strong problem-solving skills
  • Strong oral and written communication skills
  • Proficiency working in a team environment
  • Strong Leadership skills and mentoring capabilities
  • Experience in mobile software development, ex. iOS, Android
  • Experience in web based technologies, ex. HTML5, Javascript, CSS, Cordova, or Xamarin
  • Experience in Open Source development platform/tools, ex. Eclipse
  • Experience in Microsoft Visual Studio development platforms/tools, Microsoft TFS, Microsoft Azure


Posted: December 20, 2017, 8:27 am
Category : Technicians
Job Type : Contract
Id : 7184
Region : Twin Cities

Seeking a Manufacturing Engineering Technician to be responsible for performing installation of hardware, hardware diagnostics, maintenance, and repairs, including multi-vendor maintenance with customer satisfaction and asset management as additional areas of responsibility. This position requires customer interaction while performing repairs, installations, etc. This also requires ability to work nights, weekends, overtime, flex shifts, and on-call times. Requires excellent interpersonal and relationship skills, and an innovative approach to problem-solving. A commitment to quality and customer service also required. Loading and unloading of parts, tools and equipment required. Bending, stooping, walking, and lifting in excess of 25 pounds required. An Associate’s degree in electronics, photonics, manufacturing, or pneumatics is preferred; equivalent experience is acceptable.



Posted: December 20, 2017, 6:48 am
Category : Software Engineer
Job Type : Contract
Id : 7183
Region : Twin Cities

Seeking an experienced Software Engineer to be responsible for defining, implementing, executing, and documenting software for the next generation of medical device software products. The activities will encompass all facets and phases of software engineering test activities, meeting all regulatory standards, to realize complex, innovative, high reliability systems that improve the quality of life of people around the world.

As a Software Engineer II, you will be working with a motivated, diverse, and knowledgeable development team to deliver world-class products.

POSITION RESPONSIBILITIES:

  • Work in a team of software engineers to the design, develop, and verify software products in an agile environment (SAFe).
  • Support the test automation strategy and implementation.
  • Meet all project milestones and deliverables, as required by the project leadership.
  • Assist in creating and maintaining product documentation (requirements, specification, design, development, integration, test procedures and results).
  • Provide concise, timely, and accurate reports and status of all test activities.
  • Participate in continuous process improvement activities.
  • Apply best practice techniques to meet all regulatory compliance requirements.
  • Keep abreast of technical and industry trends related to Software Design and development

BASIC QUALIFICATIONS:

  • BS with 4+ years of experience in software development; or MS with 2+ years’ experience in software development.

PREFERRED QUALIFICATIONS:

  • BS and/or MS in Computer Science or Computer Engineering.
  • 2+ years of experience with Java development and Object Oriented Design.
  • Demonstrated successful implementation of a software application in a prior environment.
  • Demonstrated excellent written and verbal communication skills.
  • Broad knowledge of software test architecture and software tools for Web and mobile software applications.
  • Practitioner of Agile software development, including TDD, and experience leading a scrum team as a Scrum Master Experience with Android development
  • Experience in layered architecture, MVC, Design Patterns
  • Experience with HTML5, CSS, Javascript and Javascript frameworks
  • Experience with web languages like Ruby, PHP, or Python
  • Experience defining XML and JSON
  • Experience with configuration management tools and best practices (GIT, SVN, etc.).
  • Good understanding of Continuous Integration environments (Jenkins, Bamboo, ElectricCloud)
  • Understanding of basic Agile Tools (Rally, VersionOne, Jira)
  • Ability to generate concise and timely report, including project metrics.


Posted: December 19, 2017, 8:55 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7182
Region : Twin Cities

Seeking a Manufacturing Engineer to work with development group to develop processes for new battery designs for Medical Devices. Identify and qualify essential tooling and equipment to produce highly capable and high yielding assembly processes. Utilize statistical methods to develop robust process settings. Complete IQs/OQs/PQs as needed to support program.

BASIC QUALIFICATIONS:

  • BS Technical Discipline
  • 3-5 years experience in engineering field with experience in tooling/fixture design.
  • Working knowledge of MS Office applications (Word, Excel, PowerPoint.)
  • Working knowledge of DOE and statistical software.
  • Excellent oral and written communication skills.
  • Familiarity with poke-yoke theory.
  • Ability to work effectively in team environment.


Posted: December 15, 2017, 3:04 pm
Category : Reliability Engineer
Job Type : Contract
Id : 7180
Region : Twin Cities

Seeking a Principal Reliability Engineer to be responsible for providing key technical expertise and quality leadership non-implantable medical software systems, helping to ensure they exceed the requirements and expectations of patients, clinicians, regulators and the business. This position spans the full range of the product life cycle from development and market release to sustaining our software products following market launch. The primary focus will be on leading and facilitating the Quality and Reliability activities while collaborating with the product design and development teams. But this position will also play a critical role in defining and expanding software reliability expertise within the company. This candidate will also serve as both a technical leader and a change agent, working collaboratively with multiple business functions. As such, this role is expected to have a mastery of reliability engineering standards, technical principals, theories, concepts and tools, effective communication skills that serve a broad range of audiences (both technical and non-technical), and the leadership skills needed to be recognized as a subject matter expert and primary technical contact for reliability on projects and/or programs.

POSITION RESPONSIBILITIES:

  • The primary responsibility is for the quality of company products which support the monitoring and follow up of patients with implanted cardiac devices.
  • Understand the importance of product performance, functions, and product use environments to appropriately and strategically apply technical knowledge, reliability tools and reliability methodologies to drive reliability improvements
  • Define the approach and methods to prove and demonstrate reliability from the beginning, including the identification and proper collection of performance objectives, design requirements, measures and metrics
  • Proactively design in reliability and perform analysis against features, requirements, architecture, interfaces, and designs, through the appropriate application of reliability engineering techniques
  • Work collaboratively with Design Engineering, Development, Test Engineering, Regulatory Affairs, and other cross-functional partners

REQUIRED QUALIFICATIONS:

  • BS in Software Engineering, Computer Science, Reliability Engineering, Systems Engineering, Electrical Engineering or equivalent field
  • 7 years’ relevant experience with a Bachelor’s or 5 years’ relevant experience with a Master’s degree
  • Excellent critical thinking and problem solving skills, including application of structured problem solving methods and tools
  • Strong written and oral communication skills, including the ability to clearly and concisely summarize complex technical concepts and problems
  • Strong collaboration and influence skills
  • Fluent in English (both oral and written)

PREFERRED QUALIFICATIONS:

  • Advanced degree in engineering, science, or equivalent field
  • Certified Reliability Engineer (CRE), Certified Software Quality Engineers (CSQE) or equivalent certification
  • Experience in software fault tolerant design, fault prevention techniques, design for testability methods, software FMEA and FTA
  • Experience with Software Reliability Engineering models including growth models
  • Experience in the design, maintenance, or continuation engineering of released software or software systems, including mobile applications
  • Experience with automated and/or manual software tests
  • Experience with Agile or behavior-based development
  • Experience with C, C++, C#, Java, Perl, Python
  • Experience working with Unix/Linux, system libraries, file systems, client-server protocols
  • Experience with network theory (TCP/IP, UDP, ICMP), MAC Addresses, IP packets, DNS, OSI layers, load balancing
  • Experience in medical devices or other regulated industry
  • Experience working with IEC 62304
  • Knowledge of Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), Design for Reliability and Manufacturability (DRM), or other robust design practices


Posted: December 12, 2017, 6:44 am
Category : Technician - R&D
Job Type : Contract
Id : 7179
Region : Twin Cities

Seeking an R&D Test Technician with Medical Device experience to support the work of engineers by building prototypes, testing product, developing/ maintaining equipment and fixtures, and collaborating on problem investigations. This position will run some projects, including performing tests, interpreting data, and developing reports.  Also, operate and maintain equipment, and reports data in the mechanical or electromechanical areas.

 

POSITION DUTIES:

  • Independently set up test equipment and efficiently execute manual and automated tests at system, subsystem, and component levels.
  • Independently document test results, assuring appropriate detail to meet quality system requirements. 
  • Assist in creating fixtures, test equipment, and/or devices
  • May build and test mechanical models.
  • Maintain a clean and organized work area.
  • Follow established environmental, health, and safety procedures.
  • Follow applicable quality system procedures governing development of a medical device.
  • Ensure appropriate calibration and maintenance of test equipment, including facilitation with supporting resources.
  • Organize and maintain lab stocks of consumable supplies & subcomponents in the work area.

 

REQUIRED SKILLS:

  • Strong attention to detail and task organizational skills
  • Operate well in a team environment
  • Proficient computer skills with office software applications
  • Proficient use of basic data analysis tools
  • Strong written and verbal communication skills
  • Proficient use of test equipment

 

REQUIRED EXPERIENCE:

  • Minimum of associate degree in mechanical technology, chemical technology, electronics technology, or related technical filed.
  • Preferred 4-year degree in engineering technology or closely related technical field.
  • Minimum of 3-5 years hands on experience working with similar technologies and at the level as described in the skills section above, including automation.
  • Preferred greater than 10 years of industry experience working with similar technologies and at the level as described in the skills section above.    


Posted: December 11, 2017, 1:24 pm
Category : Technicians
Job Type : Contract
Id : 7177
Region : Twin Cities

Seeking a Senior Manufacturing Engineering Technician to be responsible for performing installation of hardware, hardware diagnostics, maintenance, and repairs, including multi-vendor maintenance with customer satisfaction and asset management as additional areas of responsibility. This position requires customer interaction while performing repairs, installations, etc. This also requires ability to work nights, weekends, overtime, flex shifts, and on-call times. Requires excellent interpersonal and relationship skills, and an innovative approach to problem-solving. A commitment to quality and customer service also required. Loading and unloading of parts, tools and equipment required. Bending, stooping, walking, and lifting in excess of 25 pounds required. An Associate's degree in electronics, photonics, manufacturing, or pneumatics is preferred; equivalent experience is acceptable.

This is a Third Shift position (10 PM - 6 AM)



Posted: December 8, 2017, 1:47 pm
Category : Technicians
Job Type : Contract
Id : 7178
Region : Twin Cities

Seeking a Manufacturing Engineering Technician to be responsible for performing installation of hardware, hardware diagnostics, maintenance, and repairs, including multi-vendor maintenance with customer satisfaction and asset management as additional areas of responsibility. This position requires customer interaction while performing repairs, installations, etc. This also requires ability to work nights, weekends, overtime, flex shifts, and on-call times. Requires excellent interpersonal and relationship skills, and an innovative approach to problem-solving. A commitment to quality and customer service also required. Loading and unloading of parts, tools and equipment required. Bending, stooping, walking, and lifting in excess of 25 pounds required. An Associate's degree in electronics, photonics, manufacturing, or pneumatics is preferred; equivalent experience is acceptable.

This is a second shift position (2-10 PM)



Posted: December 8, 2017, 1:46 pm
Category : Software Test Engineer
Job Type : Contract
Id : 7172
Region : Twin Cities

Seeking a Design Automation Engineer with the following experience:

Position Requirements:

  • Bachelors degree in Computer Science
  • 2+ years related experience
  • Experience with Windows Server (2008 or higher)
  • Experience with Database Administration
  • Two year experience with a Structured/Scripting Language (e.g. any of the following: C, C++, Java, JavaScript)

Preferred Experience:

  • Experience in Software testing and Validation
  • Experience working in a regulated environment
  • Experience with Cognition Cockpit Requirements Management Tool


Posted: December 6, 2017, 6:24 am
Category : Test Engr - Technical
Job Type : Contract-to-Hire
Id : 7162
Region : Twin Cities

We are in need of a Manufacturing Test Engineer / Computer Engineer (BS) with 2 to 5 years of experience in designing test systems for embedded products. The primary need is for a Manufacturing Test Engineer, but candidates meeting the criteria below with only design verification and validation testing experience will also be considered.

Required:

  • Comfortable in the use of Linux and knowledge of uBoot or other bootloaders
  • Experience programmatically interfacing with common test instruments:
  • Programmable Power Supplies
  • Digital Acquisition (DAQ) units
  • Comfortable programming in C, C++, Python or other languages typically used on embedded products
  • Experience in creating NI LabView vi modules
  • Excellent writing skills and experience creating one or more of the following
  • Manufacturing test plans
  • Requirements and specification documents
  • Design verification test plans
  • Software and hardware design documents

Highly Desirable:

  • Experience in creating NI TestStand sequences
  • Experience in creating and loading Yocto onto embedded devices
  • Experience using Git
  • Experience programmatically interfacing with RF test instruments:
  • Cellular, BT, Wi-Fi simulators (e.g., R&S CMW 500)
  • Spectrum Analyzers and Power Meters
  • Vector Signal Generator/Analyzer
  • Designing and creating specifications for probe fixture design


Posted: November 28, 2017, 10:48 am
Category : R&D Engineer
Job Type : Contract
Id : 7163
Region : Twin Cities

Seeking a R&D Engineer to be a member of the team responsible for changing the way we develop our new Medical Device products. This position will support and help the product development core teams to execute their programs focusing on the right product with the right design at the right time.

 

POSITION RESPONSIBILITIES:

  • Assist in developing the training framework for the Predictable Product Development initiative
  • Develop work document templates that support the generation, documentation and technical review of specific development outcomes (e.g. needs, requirements, concepts, models and analyses) by the core teams
  • Train and support the core teams on the use of the work document templates
  • Maintain the work documentation framework
  • Travel: 10-20%

 

POSITION QUALIFICATIONS:

  • Bachelor's Degree in Mechanical Engineering
  • 3+ years of engineering experience in an industrial setting
  • Strong analytical and problem solving skills
  • Experience with developing and using predictive engineering models in new product development
  • Proficiency in Microsoft Word, Excel and PowerPoint
  • VBA programming experience
  • Self-starter with strong work ethic and initiative in accomplishing objectives
  • Strong organization and time management skills; ability to manage multiple priorities
  • Attention to detail, thoroughness
  • Strong written and verbal communication
  • Able to work in cross-functional and cross-cultural teams

 

PREFERRED QUALIFICATIONS:

  • Basic knowledge of Engineering Statistics
  • Proficient in the use of Minitab statistical software
  • Experience with Monte Carlo simulation


Posted: November 28, 2017, 9:44 am
Category : Systems Engineer
Job Type : * Select Type
Id : 7161
Region : Twin Cities

Seeking an experienced Test Engineer to work within an Implantable Medical Device Product Development organization. We are looking for an individual with a strong background in systems engineering and is passionate about system maturity/reliability, integration, characterization, verification, and validation. The ideal candidate would be someone with relevant educational and/or demonstrated experience maturing complex systems with significant electrical components.

POSITION RESPONSIBILITIES:

  • Work with peer systems engineer(s) during development of user needs & intended uses and design input requirements to ensure they are validate-able and verifiable respectively.
  • Authors a system level Verification & Validation Plan, documenting scope of system V&V effort, while working with product/functional engineers to ensure proper and complete coverage.
  • Authors Integration Plan and corresponding test protocols during design development phase of project to progressively and predictably build design maturity. Executes tests per defined Integration Plan.
  • Works with various stakeholders to understand scope of characterization needed, including need to understand design capability. Executes system characterization efforts.
  • Influence product/component integration and characterization plans in order to assist in incremental system maturity. Works with engineers in various functional departments to achieve results.
  • Authors design verification and design validation protocols and reports. Executes system verification and validation activities.
  • Works with Human Factors engineer to ensure inclusion, tracing and proper coverage of applicable user needs in their summative usability study.
  • Works with Clinical to ensure inclusion, tracing and proper coverage of applicable intended uses in their pre-clinical or clinical study.
  • Plan and execute Test Method and Non-product software validation, and equipment and tooling qualification, per project needs.
  • Monitors progress of assigned tasks to defined project schedule.
  • Produce high quality deliverables while complying with relevant SOP.
  • Authors Summary report and other relevant inputs for submission by Regulatory Affairs to regulatory agencies in support of market release review and approval.

BASIC QUALIFICATIONS:

  • 7+ years of job-related experience with a Bachelor's degree; or 5+ years of job-related experience with a Master's degree.

PREFERRED QUALIFICATIONS:

  • Bachelor's or Master's Degree in Biomedical Engineering, Systems Engineering, Electrical Engineering, Computer Science, Reliability Engineering, or Mathematics.
  • Experience in engineering and testing mission critical systems and/or medical device systems.
  • Demonstrated experience maturing System with significant electrical component.
  • Experience working with detailed requirements and traceability in order to author test plans, protocols, and reports.
  • Experience working in cross-functional team effort.
  • Demonstrated strong verbal/written communication and influence management skills.
  • Proven ability to accomplish critical project level objectives in a team environment.
  • Knowledge of or experience working with Systems Engineering principles.
  • Knowledge of or experience working in a regulated and/or FDA medical device environment.
  • Knowledge of or experience working with ISO and Quality System Regulation requirements.


Posted: November 17, 2017, 12:11 pm
Category : Technicians
Job Type : Contract
Id : 7137
Region : Twin Cities

Seeking a Principal Test Technician who will provide reliability engineering support and to perform electrical, mechanical and animal testing for AF Solutions products. This will include system level evaluation test method development and testing. This position will work closely with reliability, operations and system/development engineers to qualify new products and/or perform design characterization testing on new designs. 

POSITION RESPONSIBILITIES:

  • Responsibilities include designing, documenting and executing various electrical, mechanical and animal/cadaver tests for the purposes of design characterization and design verification testing. Also includes preparation of devices for testing including, environmental preconditioning, temperature and humidity cycling and transportation cycling. 
  • Design, source, fabricate, assemble, modify and finish high quality test fixtures and equipment. Expert working knowledge of electronic design software, including Allegro. Additional mechanical CAD knowledge with Pro Engineer / Solidworks as well as PDM Professional software or other CAD packages is preferred. Experience with automated software programs such as LabView is a plus. 
  • Perform process or conduct tests from technical objectives to characterize, verify and validate the functionality of hardware, software, systems, test procedures or process designs. 
  • Fully understands the usage of test instruments and fixtures. Is a resource within the organization on test instrumentation and test setups.  Understands how to use lab tools like Instron pull tester (with Bluehill software) and toolmaker microscope with quadra-check measurement system. Ability to work with labview software and program data collection tools is preferred. 
  • Trains others on proper instrumentation usage and test setups. 
  • Partners with engineering to define departmental procedures for data collection, analysis of data and documentation of results. Develops team members to properly collect data and prepare documentation. 
  • Review data versus expected results as defined in product documentation, specifications, technical objectives and/or from past experience and system knowledge. Identify use conditions and trends. Collects appropriate data to assist with root cause analysis. 
  • Serves as a resource to cross-functional areas providing technical expertise in testing methods and test execution. 
  • Suggests new methods and innovative uses of existing tools and equipment. Identify opportunities for added efficiency. Implements or provides leadership in implementing as appropriate. 
  • Expected to balance a complex personal workload and may provide leadership to balance the workload for a project team within the functional area ensuring all commitments are met. Communicates progress concerns in a timely manner and provides alternative solutions. 
  • Provide leadership in process definition and process improvements for lab support activities. Owner of lab support administration activities. 
  • Provides feedback on the clarity, purpose and scope of technical deliverables and objectives and suggests improvements. 
  • May establish test execution schedules, ensuring all project participants support the customer expectation. 
  • Proposes improvements in products and/or processes and may participate in design reviews. 
  • Participates in issue analysis activities suggesting methods for collecting data to help define root cause. 
  • Support troubleshooting and problem solving efforts related to development and sustaining engineering projects. 
  • Work effectively and efficiently in a team environment, promotes harmony and constructive issue resolution. 

JOB QUALIFICATIONS 

  • Associate in applied Science Degree, 2 year technical college degree or equivalent 
  • 10-15 years of experience in design and/or mechanical technician type work 
  • Regulated environment experience such as Medical Device or Hospital/clinic experience
  • Communicates clearly and effectively with associates and management as required. 
  • Good documentation, record keeping and data collection skills – attention to detail. 
  • Possess the ability to plan time and resources to attain objectives on time and within budget 
  • Demonstrated ability to plan and manage one's own work. 
  • Work tasks and products are managed and presented using MS Excel and PowerPoint. 
  • Proficiency with design standards and GD&T principles 
  • Experience designing catheters and Radiofrequency generator knowledge 
  • Familiarity with Instron, Matlab, LabView, QuadraCheck measurement systems 
  • Experience analyzing data in Minitab
  •  Proficiency with ProEngineer/SolidWorks 

 

SKILLS/COMPETENCIES 

  • Passion for combining heads down design with hands on application of design principles 
  • Proficiency with ECOing design changes 
  • Proficiency w/ MS Office applications: Word, Excel, PowerPoint 
  • Strong communication and organizational skills 
  • Able to work around blood, tissue, animal and cadaver models 
  • Able to travel internationally (Canada)
  • Team project experience in professional, academic or other setting 
  • Understanding of basic blood physiology and human anatomy 
  • Experience completing tests and studies in lab environment


Posted: November 3, 2017, 7:32 am
Category : Controls Engineer
Job Type : Contract-to-Hire
Id : 7131
Region : Twin Cities

We are currently seeking an Electrical Controls Engineer with experience designing automation equipment for the medical device industry and other high-end manufacturers.  A successful candidate will be comfortable working in a small company environment and possess the skills and attitude to perform work spanning across multiple roles and responsibilities.

 

Position Responsibilities:

  • Participate in initial equipment conceptual development and carefully balance product specifications, process requirements, layout complexity, cost, and lead-time limits.
  • Architect, write, and debug PLC ladder logic and Structured Text with an emphasis on generating code that is organized, structured, documented, maintainable and reusable. PLC code will interact with subsystems such as conveyors, robots, Manufacturing Execution System (MES), LabView, machine vision, and 3rd party equipment.
  • Manage electrical cabinet builds, field wiring, pneumatic and fluid plumbing.
  • Generate aesthetically simple HMI screens for complex machinery while providing sufficient feedback for troubleshooting.
  • Layout industrial control panels that are NFPA79/NEC/UL508A compliant.
  • Select and size electrical and electromechanical components, such as servos.
  • Diagnose and solve electrical problems.
  • Interface with customers.
  • Update and maintain project schedules.

 

Position  Requirements:

  • BS in Electrical Engineering.
  • 3+ years designing machines within the medical device industry.
  • Proficiency in AB, Adept, Beckhoff, Cognex, Datalogic, Denso, GE, Horner, Mitsubishi and Omron
  • VB.Net desirable.
  • Must be self-motivated.
  • Must have excellent communication skills.
  • Must be flexible and willing to adapt to changes and short deadlines.


Posted: October 27, 2017, 9:56 am
Category : Electrical Power & Lighting
Job Type : Permanent
Id : 7122
Region : Twin Cities

Qualifications / Requirements:

  • BSEE with a minimum 5 years of engineering design experience
  • Must have a Minnesota PE in electrical engineering
  • Specify and design the installation of medium voltage, relaying, low voltage switchgear and motor control equipment
  • Must have a minimum 2 years’ experience in power system engineering analysis using SKM software
  • Good working knowledge of the current National Electrical Code
  • Capable of producing and supervising the production of industrial electrical construction drawings, specifications, and other documents
  • Proven communication skills and the ability to supervise project teams are required along with the ability to work closely with clients and teams from other disciplines
  • Ability to travel from time to time as needed

Responsibilities:

  • Apply the company’s engineering principle to complete engineering designs associated with the capital projects
  • Technical and execution activities will be performed including system studies, specifying hardware, calculations, preparing and performing project estimates, scheduled, effort-hours, and material forecasts to ensure consistency with engineering standards and operating principles.
  • Perform plant Short-Circuit, LV/MV Coordination and Arc Flash studies using the SKM power tools software.
  • Lead the marketing of power system engineering analysis efforts to internal / external clients
  • Supervision of project teams will be required


Posted: October 25, 2017, 8:06 am
Category : Technician - R&D
Job Type : Contract
Id : 7118
Region : Twin Cities

Seeking a Dialysis R&D Test Technician to provide engineering test support for the development of hemodialysis machine.

Duties of Position:

  • Independently set up test equipment and efficiently execute manual and automated tests.
  • Accurately and thoroughly document test results to meet quality system requirements.
  • Ensure appropriate calibration and maintenance of test equipment.
  • Organize and maintain lab stocks of consumable supplies in the work area.
  • Maintain a clean and organized work area.
  • Follow established environmental, health, and safety procedures.
  • Perform data analysis and summary using Microsoft Excel, Word, and PowerPoint.
  • In consultation with others, prepare test protocols and test reports.
  • Follow applicable quality system procedures governing development of a medical device.

Position Requirements:

  • Associate degree in a technical field such as electronics, mechanical technology, chemical technology.
  • Minimum 2 years' experience in engineering test supporting new product development
  • Ability to maintain focus and attention to detail in setting up, executing and documenting mechanical tests.
  • Proficiency with Microsoft Excel to perform data entry, modest data analysis such as basic graphs and summary statistics, and ability to format data as requested for export to other programs.
  • Proficient with standard test and measurement equipment, such as multi-meters and oscilloscopes, thermocouples and RTDs, pressure transducers, flow meters, conductivity cells, pH sensors, weight scales, and calipers.
  • Basic chemistry lab skills to measure ingredients, prepare solutions, and perform simple test measurements such as pH and conductivity.
  • Ability to work with hand and power tools, including operation of drills, power saws and mills to perform minor fabrication and modifications.
  • Proficiency with Microsoft Word to prepare and document test protocols and test reports.
  • Proficiency with Microsoft PowerPoint to create simple diagrams, figures, and schematics to document work performed.


Posted: October 16, 2017, 11:56 am
Category : Quality Manager
Job Type : Permanent
Id : 7115
Region : Twin Cities

Seeking a Senior Regulatory Specialist to work with Quality Assurance Teams that are responsible for conformance and continuous improvement initiatives within the company. To work on systemic evaluation of products, services, facilities, manufacturing or business processes, to ensure that standards of quality are being met. Develop and implement quality plans, programs and procedures using quality control statistics, lean manufacturing concepts, and six-sigma tools and analyses. This position will review, analyze and report on quality discrepancies, investigate problems and executes quality audits, and develops disposition and corrective actions for recurring discrepancies. The team works closely with manufacturing, engineering, customers, or suppliers and subcontractors to ensure requirements are met.

 

Responsibilities & Qualifications:

  • Manages the Regulatory Affairs function
  • Develops global regulatory strategies
  • Ensure compliance to 231 CFR 820, ISO 13485, MDD/MDR, MDSAP, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Provides Regulatory leadership to development teams, e.g., global regulatory strategies and cross functional alignment with issues of possible Regulatory ramifications and mentoring junior regulatory staff.
  • Acts as a liaison with Quality, R&D, Legal, and Operations.
  • Provides technical guidance and training to staff
  • Responsible for submission preparation and development of labeling, marketing or promotional materials, training on departmental policies and procedures, new FDA guidance documents, and FDA warning letters, competitor updates.
  • Prepares submissions for device design changes and /or manufacturing changes.
  • Reviews product and manufacturing changes for compliance with applicable regulations (Change Control).
  • Reviews protocols and reports to support regulatory compliance and submissions.
  • Reviews device labeling and advertising materials for compliance with applicable regulations.
  • Builds partnerships and mutual respect with regulatory authorities (e.g., FDA, Notified Body).

 

Position Qualifications:

  • Bachelor's degree (BS, BA) (technical discipline preferred) with at least 3 years' medical device and regulatory experience.
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
  • Ability to work effectively within a team in a fast-paced changing environment.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Ability to travel approximately 10%, including international

 

Posted: October 11, 2017, 7:53 am
Category : Software Engineer
Job Type : Contract
Id : 7103
Region : Twin Cities

 

 

Seeking a Jr Level Software Quality Engineer with spreadsheet validation experience to review Company spreadsheets and procedures, write the plans and reports, and log all of the validation efforts into company system. This candidate will lead the validation effort in legacy spreadsheets that are used to make quality decisions based on measurement results. They will document the functionality of the spreadsheet; the calculation used; and provide evidence that the calibration specification is met.

 

Basic Qualifications:

  • Engineering Bachelor's Degree with at least 1 year related professional experience.

 

Preferred Qualifications:

  • Must have experience in a quality management system.
  • Must have solid written communication skills
  • Proficient using MS Office software, excel, word, power point.
  • Experience in reviewing manufacturing specifications
  • Experience in validation documentation
  • Experience in revision control software
  • Experience in software test automation
  • Experience in review calibration procedures


Posted: September 26, 2017, 1:17 pm
Category : Controls Engineer
Job Type : Contract
Id : 7100
Region : Twin Cities

Excellent opportunity for Controls Automation Engineer to support design and programming of manufacturing / test equipment used in the development and production of medical device products.

 

Requires BS degree (EE, CS) and experience in design and programming of complex industrial machine control systems. This includes PLC / HMI programming, control panel / hardware design, and system troubleshooting and start-up.

 

2-5 years of experience in automated system design, and will consider junior level candidates with control system training and some hands on automation experience.

 

Prefer experience with Allen Bradley/Rockwell Automation PLC and HMI, robotics, motion control, vision systems (Cognex) programming, and system validation and start-up.

 

Prefer experience with SAP and Manufacturing Execution Systems (MES). Experience working within an FDA (or similar) regulated validation and documentation process preferred, and experience with Visual Basic / .NET programming and SQL database development is a plus.



Posted: September 25, 2017, 8:16 am
Category : Technician - General
Job Type : Permanent
Id : 7095
Region : Twin Cities

Seeking an Automation – Robotic Service Technician to perform successful start-ups and training of company automated bag filling, bagging and bag closing equipment. Also Perform start up service of equipment related to electrical, mechanical, and pneumatic parts. Apply knowledge of electrical and mechanical principles in determining equipment malfunctions and applies skills in servicing and trouble-shooting equipment issues.

POSITION RESPONSIBILITIES:

  • Direct and assist customers in the installation, start-up and training of company's Robotic Palletizing lines.
  • Provide technical service support to customers when their machines are not performing as required.
  • Provide the Engineering Department with accurate updates on all changes made to machines in the field.
  • Be an integral part of the team for final checkout of machines assuring they are ready for shipment. This includes performing quality checks at all assembly levels and documenting final quality checks.
  • Be technically competent, mechanically and electrically, with the ability to move through PLC programs easily.
  • Assemble and set up robotic palletizing lines from layout drawings, electrical schematics and BOM's while in the shop.
  • Make recommendations for design and manufacturing process improvements.

POSITION REQUIREMENTS:

  • 2-year degree in Robotics/Automation
  • 1 or more years of experience in robotic and automation machine building
  • Excellent mechanical/electrical capability or capacity to achieve
  • PLC/servo and Robotics/Motoman and/or Fanuc experience.
  • Solid mechanical problem solving skills
  • Potential to be a motivator/leader
  • Professional communication, attitude and image
  • Good verbal and written presentation, as well as being organized, a good planner and having good interpersonal skills
  • Based in the Minneapolis/St. Paul area
  • Must supply their own basic tools
  • TRAVEL - Up to 50%


Posted: September 19, 2017, 9:00 am
Category : Sales
Job Type : Permanent
Id : 7087
Region : Twin Cities

 

Do you enjoy participating in people's success stories? Development Resource Group is a Twin Cities leader in engineering staffing and we are looking to for a high energy, sales focused professional to add to our growing team. The technical and fast paced staffing industry provides an opportunity to directly benefit the growth of our consultants and clients.

 

As a Business Development Manager you will maintain and grow existing clients, along with pursuing and developing new relationships and opportunities to increase sales with local companies. Additionally, you will be responsible in supporting all contracted staff though the duration of their project, working to ensure both client and consultant's satisfaction.

 

Preferred Qualifications:

  • Bachelor's Degree
  • 4 years+ of experience in B2B Sales
  • Minimum of 2 years in the staffing industry, sales or recruiting

 

Posted: September 14, 2017, 7:15 am
Category : Software Applications Engineer
Job Type : Permanent
Id : 7047
Region : Twin Cities

Seeking a Software Development Engineer to participate as part of a development team in the complete software development of a proprietary Linux-based data acquisition system.   This position requires interfacing with data acquisition hardware and implementing real-time data streaming systems.

 

Responsibilities:

  • New feature and function design and development
  • Maintenance/administration of existing products and environment
  • Testing and documentation
  • Other duties as assigned by manager

 

Qualifications:

  • Bachelors of Science in Computer Science or Engineering
  • Minimum of 2-7 years of related experience
  • Broad knowledge of software development techniques
  • Experience with Linux, Java, C and C++
  • Database, network administration and/or data acquisition hardware experience desirable
  • Knowledge of object oriented development techniques desirable

 

Posted: August 30, 2017, 8:19 am
Category : Manufacturing Engineer
Job Type : Contract-to-Hire
Id : 7062
Region : Twin Cities

Seeking an experienced Manufacturing Engineer to initiate and lead safety, quality, service and productivity (cost) improvement projects in all aspects of manufacturing with a preliminary focus on machines and tools used in thermoforming and extrusion operations.

The ideal candidate will have a proven track record for effective project management skills for delivering projects on time and within budget. Another crucial skill for this position would be having formal training and advanced knowledge of Lean methodologies and Operational Excellence. A thorough knowledge of CAD software packages using SolidWorks, ProEngineer or Autodesk Inventor. A Six Sigma Green Belt would be a plus.

 

MINIMUM QUALIFICATIONS/REQUIREMENTS:

  • Bachelor's degree in Engineering
  • 2 years' experience in a related manufacturing environment using automated equipment
  • 2 years' direct involvement and leadership in Lean manufacturing/Continuous Improvement environment
  • High energy, entrepreneurial spirit, and a drive to succeed
  • Demonstrated results leading change, optimizing processes and implementing new programs
  • Formal training and advanced knowledge of Lean methodologies, and Operational Excellence
  • Evidence of ongoing training as required to keep skills current and relevant
  • Ability to work in a fast-paced environment with multiple priorities
  • Ability to effectively manage large amounts of data, draw informed fact based conclusions, and make timely decisions
  • Proficient with CAD drawing using either, SolidWorks, ProEngineer, or Autodesk Inventor
  • Ability to manage complex programs and use structured problem solving methodologies
  • Ability to effectively manage, develop, and deliver results with a diverse matrixed team
  • Strong verbal and written communication skills
  • Experience working with cross functional teams and communicating with individuals from the production floor to the executive level
  • Strong negotiation and persuasion skills
  • Advanced Microsoft Office and other computer application skills
  • Experience working with ERP systems

OPTIMAL QUALIFICATIONS:

  • Previous experience in two or more of the following roles: Manufacturing Engineer, Process Engineer, Quality Engineer, or similar roles with significant equipment and machine experience
  • Previous thermoforming experience
  • Six Sigma Green Belt certification
  • Advanced Business or Technical degree
  • Effective project management skills with proven track record of delivering projects on time and within budget
  • Ability to understand and apply Lean analytical and statistical tools
  • Excellent communication, problem solving, interpersonal, organizational, and analytical skills


Posted: August 22, 2017, 7:10 am
Category : Mechanical Engineer
Job Type : Permanent
Id : 7054
Region : Twin Cities

Seeking a Mechanical Engineer to perform the following duties:

  • Design custom automated machinery Using SolidWorks 3D CAD software.
  • Perform machine design calculations.
  • Specify commercial components.
  • Meet project deadlines in a cost-efficient manner.
  • Safely perform duties following quality standards.
  • Participate in team building, training and department communications.
  • Work as a team player with management and co-workers to develop a win-win partnership through positive relationships and excellent interpersonal skills.
  • Maintain a commitment to vision and “spirit” by partnering with new and current employees by demonstrating outstanding service and integrity.


Posted: August 16, 2017, 12:03 pm
Category : Electrical Designer
Job Type : Permanent
Id : 7046
Region : Twin Cities

Seeking a Control Systems Designer for both design and technician responsibilities.

Accountabilities:

  • Design electrical, controls, and facility integration systems
  • Coordinate C & I Design with lead engineer
  • Drafting
  • Specify and select hardware
  • Support systems fabrication, checkout installation and acceptance testing
  • Support customer service
  • Provide labor and material cost estimates
  • Work as part of a team
  • Perform remote site field installation, checkout, testing, and customer service including interfacing with customer
  • Travel approximately 15% of time both domestically and internationally

Skills:

  • PC skills
  • Electrical design
  • Hands on electrical assembly and installation
  • AutoCAD
  • SolidWorks Electrical

Experience:

  • Work experience with control and instrumentation equipment or design is preferred

Education:

  • Associate degree in electrical technology or equivalent
  • Due to the nature of our work US citizenship or permanent resident status is required.


Posted: August 10, 2017, 1:36 pm
Category : Electrical Engineer
Job Type : Permanent
Id : 6992
Region : Twin Cities

Seeking a Controls Project Engineer for the design, programming, and management of industrial Control Systems Projects.

 

Position Requirements:

  • Bachelor's Degree in Electrical Engineering or Computer Science
  • 2-7+ years' experience with process and machine control design
  • Experience in PLC and MMI programming (Allen Bradley, Siemens, Wonderware, Panelview, Factory Talk), communication networks design and programming, electrical hardware / panel design, and system commissioning and start-up.
  • Up to 25% travel to customer sites

 



Posted: June 28, 2017, 11:34 am
Category : Electrical Engineer
Job Type : Contract-to-Hire
Id : 6968
Region : Minnesota

 

Seeking a Controls Engineer to design and program control systems for automated equipment.  The ideal candidate would have experience in AutoCAD, Allen Bradley, ControlLogix, Motion Control, Rs500, RsView, and PanelBuilder.  As a Controls Engineer, you will be responsible to take projects from concept to install.  Bachelor's degree in Electrical Engineering and 5 years relevant experience required.



Posted: June 14, 2017, 2:48 pm
Category : Electrical Engineer
Job Type : Permanent
Id : 6940
Region : Minnesota

Currently seeking a Senior Control Systems Engineer based out of the Los Angeles area to perform all aspects of a project, from conception and design, through start-up and checkout.  Duties include project management, P&ID development, wiring diagram development, BOM specification, control panel design, PLC and HMI programming, and field commissioning. This position has the ability to work from home (based in the Los Angeles area).

 

Required Skills:

  • Minimum of BSEE with 7+ years' experience or 2-year degree with 10+ years' experience
  • Ability to lead a project from conception through start-up
  • Project management, estimating, BOM specification, electrical diagram design, NEC
  • Experience using Wonderware products
  • Allen-Bradley RSLogix 5000, PowerFlex drives experience
  • Modicon PLC experience
  • Excellent communication and teamwork skills
  • Able to travel up to 35%

 

Desired Skills:

  • Motion Control
  • Experience in the mining industry
  • Experience with small manufacturing machines
  • Web Handling experience
  • PE Registration a big plus
  • Experience with MES

 

Posted: April 26, 2017, 9:06 am
Category : Technicians
Job Type : Contract
Id : 6856
Region : Twin Cities

Immediate opportunity for an Automation Technician to support equipment build projects for medical device manufacturing. The Technician will assemble, test, and troubleshoot custom automated equipment and work cells. This includes electrical control panel wiring, motors, drive systems, mechanical enclosures, and PLC installations and check-out.

 

Preferred Skills

  • 2 year degree in Electronics or Automated Systems Technology
  • Hands on experience with equipment build
  • Must be able to read prints, schematics, and work instruction
  • Strong mechanical and electrical aptitude
  • Ability to work independently within a custom automation group
  • Knowledge and experience with PLC, HMI, and motion control
  • Medical device development environment experience is a plus



Posted: January 17, 2017, 2:33 pm
Category : Sales
Job Type : Permanent
Id : 6655
Region : Twin Cities

We are seeking a motivated and energetic individual to add to our Sales Team as an Account Representative. Account Representatives are responsible for working with our clients in establishing their needs and then working with our recruiting staff to fill those needs. Additionally, they support all contracted staff though the duration of their project, working to ensure both client and contractor's satisfaction.

 

Candidates must have excellent communication skills, a high level of computer systems knowledge, preferably technical staffing experience, be self-motivated and enjoy working in the "people business." A college degree is preferred, with several years of staffing sales experience and/or recruiting experience in a Technical or Engineering field.



Posted: May 11, 2016, 8:20 am