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Development Resource Group

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Category : QA Validation
Job Type : Contract
Id : 7763
Region : Twin Cities

Seeking a Quality Engineer to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required.

Essential Duties and Responsibilities:

  • Develop incoming inspection processes and document incoming inspection activities.
  • Provide in-process QA support to include inspection and document review.
  • Complete final acceptance activities.
  • Manage the sterilization process, including validations and product sterile loads.
  • Track nonconforming material and lead Material Review Board (MRB) efforts.
  • Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.
  • Lead complaint investigations on returned product.
  • Manage corrective action and quality improvement activities.
  • Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.
  • Assist in the performance of quality system internal auditing.
  • Support quarterly management review meetings.
  • Establish, monitor and evaluate quality system metrics.


Posted: October 22, 2019, 1:15 pm
Category : Mechanical Engineer
Job Type : Contract
Id : 7768
Region : Twin Cities

We are looking for a Mechanical Engineer with previous medical device experience and who can contribute early in production line support, investigating equipment issues, and participation in improvement projects for existing products.

Must have:

Good technical writing ability.

0 - 5 years of experience.

Mechanical Engineering or Biomedical Engineering degree.



Posted: October 22, 2019, 12:37 pm
Category : Reliability Engineer
Job Type : Contract
Id : 7767
Region : Twin Cities

Seeking a Senior Reliability Engineer who has experience with a regulated Medical Device environment. Must have understanding of Design Failure Mode Analysis, Requirement Validation/Verification Planning and Reporting process, and Risk Management & Analysis. Bachelors degree with 5+ years of experience, or 3+ years with a masters degree.



Posted: October 18, 2019, 12:08 pm
Category : Firmware Engineer
Job Type : Permanent
Id : 7766
Region : Twin Cities

We are currently hiring an Embedded Linux Software Engineer to develop embedded software for new products and maintain existing product lines through improvement updates. Preference is someone experienced working with open source tools as well as traditional embedded software technologies used in a regulated environment for medical devices.

Responsibilities:

  • Development of C/C++/C++ v11 embedded software applications for both new and existing medical devices
  • Adapt and extend existing embedded Linux applications to add new features to current products, analyze the existing architecture and if applicable, adjust and extend it to allow reuse across additional future products.
  • May coach and develop entry level engineers by sharing knowledge and best practices
  • Assist in planning, estimating, and scheduling software development efforts
  • Review, and guide technical work and issue resolution providing multiple options and ensuring that all work meets requirements and specifications in compliance with the quality system and best practices
  • Maintain frequent communication within and outside of the department in support of engineering activities and project plans
  • Assure appropriate documentation for assigned project
  • Understands and follows requirements of SOPs.
  • Contribute to corrective action development and alternatives.
  • Determine resolution of intermediate technical issues as needed and assures that technical work meets specified requirements.
  • Conducts testing for assigned projects.
  • Prepare documentation associated with engineering activities.
  • Conduct design testing.
  • Operate with a significant amount of latitude and freedom. Within these minimal constraints, may lead medium to large projects; plans and authorizes tests and approves test evaluations; directs and approves documentation and related drawings; designs components, parts or systems of significant difficulty; oversees/approves troubleshooting resolutions.
  • Perform engineering work requiring full competency in all conventional aspect of engineering
  • Plans and conducts work requiring judgment in the independent evaluation, selection and the substantial adaption of standard engineering techniques, procedures and requirements. Plans and coordinates detailed phases of engineering actions for part of a project
  • Performs assignments independently troubleshooting tasks as related to product problems.
  • Performs assignments independently with limited supervision as to expected results.
  • Independently plans, schedules, conducts or coordinates detailed phases of the assigned project.
  • Continuously reviews project team progress and evaluates results accordingly.
  • Works under only general supervision, with direction given only in terms of broadly stated objectives and desired outcomes.

Requirements:

  • Minimum Bachelor’s degree in engineering or similar. Software or Electrical Engineering preferred
  • 3-5 years of experience or 2-5 years with an advanced degree.
  • 3+ years of Embedded Linux experience (Buildroot or similar)
  • Experience writing C and C++ applications running on Linux, RTOS, bare metal, uCOS, or similar
  • Experience working with UI frameworks such as Qt, Altia or similar
  • Able to write clean, safe, readable code
  • Applies extensive technical expertise in the engineering field and has knowledge of other related disciplines (Global Product Management, Quality, Regulatory, Sales and Operations)
  • Work under only general supervision from the Engineering Manager, with direction given only in terms of broadly stated objectives and desired outcomes
  • Ability to clearly convey ideas and concepts verbally and in writing

Preferred Requirements:

  • Experience in regulated product development environments preferred
  • Experience in multiple areas of an embedded device (UI, communications, databases, drivers, OS) through all stages of the development process, including for example, requirements, architecture design, coding, test, documentation, and safety analysis highly preferred
  • Experience developing and debugging complex software systems highly preferred
  • Experience planning, scheduling, and conducting multiple phases of a software project highly preferred
  • Experience working in an Agile development environment using tools such as Git, Jira, TFS, etc.
  • Experience in python and bash scripting and creating automated test frameworks preferred
  • Experience coaching and mentoring others in technical matters and related project initiatives preferred
  • Strong influencing skills and ability to convey clear supporting evidence for proposals
  • Ability and willingness to lead and create changes in policy, procedure, technology, and culture


Posted: October 16, 2019, 7:24 am
Category : Project Manager
Job Type : Permanent
Id : 7765
Region : Twin Cities

Seeking a Project Manager to be the primary customer interface during all project phases of design, supply, production, factory testing, delivery, install, and customer site acceptance testing. This individual will be responsible for project leadership on build to print and custom automation design and build projects.

Responsibilities:

  • Provide leadership to drive project related decisions (technical & non-technical)
  • Develop detailed project plans and specification documents
  • Identify resources by discipline required for successful project milestone deliveries.
  • Work with organization management on early identification and labor durations of project resources
  • Plan and lead all internal and customer project design reviews throughout project execution
  • Execute project plans which are designed to exceed financial targets
  • Manage quality, schedule, cost, and customer satisfaction
  • Manage contract compliance as it relates to "as sold" scope, allowable deviations, scope changes requiring purchase order adders, timely release of invoicing, and payment receivables

Requirements:

  • Ideal candidate will have the ability to manage multiple projects of varying degrees of complexity simultaneously, proven leadership, planning and organizational skills, and strong technical background in automation design.
  • Candidate must demonstrate proven "systems" approach to project management and the drive to consistently deliver on commitments.
  • Qualified candidate will have a BS or MS in Engineering or Technical discipline and 8-10 years of relevant experience. Significant team leadership experience, preferably in a project environment, is desired.



Posted: October 11, 2019, 11:09 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7762
Region : Twin Cities

Seeking a Manufacturing Engineer for the evaluation of production equipment, production support, and process validation. The engineer will troubleshoot manufacturing process and equipment, protocol and report writing, generate and modify manufacturing process documentation, and develop and implement process improvements. This position requires strong organizational skills and the ability to effectively communicate a large cross functional team. Candidate should be able to work both independently and on a team.

Responsibilities include:

  • Work may involve collaborating with cross-functional teams developing and executing tests and making presentations to internal/external customers, vendors, and senior management.
  • Effectively communicates moderately complex technical issues and solutions to non-technical internal and external customers.
  • Exercises technical judgment in planning, organizing, performing, and/or coordinating engineering work.
  • Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, 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.
  • Performs other related duties and responsibilities, on occasion, as assigned

General Qualifications:

  • Bachelor’s Degree in Mechanical Engineering, or equivalent Engineering degree.
  • 0-2 years related experience
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail
  • Experience with electronic document control systems (Windchill, etc.) preferred.
  • Ability to maintain regular and predictable attendance.



Posted: October 9, 2019, 10:08 am
Category : Software Test Engineer
Job Type : Permanent
Id : 7761
Region : Twin Cities

We are currently hiring a Senior Software Verification Engineer that will establish and carry out a verification strategy for a new embedded software platform. This position will be a rewarding and innovative opportunity to apply skills and experience to establish a strategy that encompasses verification methods at all design levels with a focus on integrated automated testing. This role will be key to bringing our next generation of medical devices to market. You will be collaborating with software engineers to develop a full package for testing our new product platform and apply similar methodologies to future updates of our existing products.

The Senior Software Verification Engineer responsibilities extend to all aspects of verification including writing plans, reviewing requirements, creating automated test architecture, creating test cases, implementing tests, leading the verification team, writing reports. You will use tools such as software version control, change/issue tracking, software configuration management, test automation, and similar that are common in regulated environments. All work will be done in accordance with our internal quality system and industry standards.

Duties & Responsibilities:

  • Innovate verification/testing approaches and ideas
  • Create framework for automated test systems
  • Design, create, execute and debug automated test software, test suites and equipment with ability to maintain and leverage for follow on projects
  • Author Software Verification Plans, Traceability Reports, and Verification Reports
  • Provide verification testing at all levels of the software design
  • Able to dissect requirements into test cases
  • Able to work with developers on assuring requirements are testable
  • Design, develop, and maintain software tests and test assets
  • Perform peer review
  • Contribute to our teams’ growing set of test platforms, tools, technology, and processes
  • Track and report on test development and execution status
  • Present verification progress at weekly staff meetings
  • Understand all testing deliverables and be able to speak to them and navigate if asked
  • Good team player working with development team members, leaders and mentor others in testing activities
  • Able to lead team on test execution and anomaly handling

Requirements:

  • Minimum Bachelors’ Degree in Engineering and Minimum of 5-8 years of experience in software verification, principles, theories, concepts and techniques OR
  • 3-6 years’ experience with advanced degree
  • Programming languages C/C++ and scripting languages
  • Knowledge of various embedded software verification tools including advantages and disadvantages of each
  • Ability to lead a team of 2-6 test engineers
  • Ability to implement automated test practices to a blend of development and test engineers
  • Ability to anticipate choke-points and plan around them
  • Excellent verbal and written communication skills
  • Experience working in a regulated industry, medical device - preferred
  • Agile software life cycle and development – preferred
  • Requirements based testing using formal processes and procedures – preferred
  • Knowledge of Quality Assurance industry standards and procedures and FDA guidance


Posted: October 7, 2019, 12:22 pm
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7757
Region : Twin Cities

Seeking a Quality Engineer to initiate medical device quality assurance activities. These activities must be in accordance with FDA Quality System Regulation, ISO13485 and other international standards. This position will also support device complaint investigation and failure analysis as required.

 

Essential Duties and Responsibilities:

  • Develop incoming inspection processes and document incoming inspection activities.
  • Provide in-process QA support to include inspection and document review.
  • Complete final acceptance activities.
  • Manage the sterilization process, including validations and product sterile loads.
  • Track nonconforming material and lead Material Review Board (MRB) efforts.
  • Interface and take lead QA role in interactions with suppliers, contractors and consultants that supply components, subassemblies and contract processing.
  • Lead complaint investigations on returned product.
  • Manage corrective action and quality improvement activities.
  • Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc.
  • Assist in the performance of quality system internal auditing.
  • Support quarterly management review meetings.
  • Establish, monitor and evaluate quality system metrics.



Posted: October 4, 2019, 12:05 pm
Category : Systems Engineer
Job Type : Contract
Id : 7760
Region : Twin Cities

Seeking a Principal Systems Engineer to perform RFD (Requirements Flow Down) work including preparing systems documentation and performing requirements traceability including DIS, DI/DO tracing and EDO tracing (Design Input Sources, Design Input / Design Output tracing, Essential Design Outputs tracing). The work will performed using various tools including Cognition Cockpit and Excel spreadsheets. This position will involve providing systems support to the DV team through consultation, test plan authoring, test method design and validation and collaboration. This position will work under general direction with some latitude to determine technical objectives of assignments. They may provide work direction to other engineers and technicians. They will provide accurate resource and timeline estimates for their area of responsibility.

Position Requirements:

  • Bachelors degree
  • Strong collaborator, strong communicator, works well in a fast-paced team environment.
  • A minimum of 5 years as a SysE working in electronic embedded systems that utilized GUIs (Graphical User Interfaces).


Posted: October 3, 2019, 6:44 am
Category : Quality/Regulatory
Job Type : Contract
Id : 7756
Region : Twin Cities

Seeking a detail-oriented, proactive Certification Project Manager to run numerous certification projects.  Project coordination entails being main point of contact for customer, arranging certifications with test labs,

 

Position Description:

  • Work with test labs and other certification experts to determine what is needed to be able to certify current Company products for sale in counties outside of North America and Europe
  • Gather certification quotes from test labs and estimate support labor for potential certification projects.
  • Writing statement-of-work documents, which function as project proposals
  • Consult with internal Company employees to find test reports, product information, and any other information or help needed to complete new country certifications for existing Company products
  • 30+ hours per week
  • Certification/regulatory experience required

 

Posted: September 26, 2019, 1:24 pm
Category : Packaging Engineer
Job Type : Contract
Id : 7754
Region : Twin Cities

Looking for a talented Packaging Engineer to be responsible for providing technical knowledge and leadership to identify and implement packaging support. Ability to effectively coordinate activities among the other areas of the plant and project teams is critical to be successful. Primary job responsibilities include: provide technical expertise on a wide range of packaging issues, apply leadership skills to manage projects and establish organizational alignment through effective communication. This position functionally resides in the plant engineering group, reporting directly to the Manager of Engineering. Must have ability to interface directly with related Supply Chain functions and Commercial organizations. In addition, must effectively work with external partners that supply packaging commodities.

Qualifications:

  • Minimum of 4-8 years of experience in technical package engineering position or related field.
  • Bachelor’s Degree or equivalent experience required.
  • Thorough technical knowledge of a wide range of packaging materials, structures and manufacturing processes.
  • Ability to prioritize and manage multiple priorities.
  • Demonstrated leadership skills.
  • Excellent communication skills.
  • Ability to effectively interface with broad cross functional teams.
  • Demonstrated ability to make decisions independently.


Posted: September 25, 2019, 2:13 pm
Category : Quality/Regulatory
Job Type : Contract
Id : 7753
Region : Twin Cities

Seeking a Design Assurance Engineer to work closely with Development/Manufacturing/Quality Engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. Monitor quality assurance efforts to ensure that the company’s products conform to quality standards. Partner with Research/Development and Manufacturing Engineering during new product start-ups and establish checkpoints for testing new products and processes.

The Design Assurance Engineer is responsible for following established GMP/ISO compliant quality system practices.

  • Ensure company’s adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.
  • Lead design assurance activities in support of development for electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs and software applications.
  • Manage new product Design History Files.
  • Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.
  • Aide in definition of test equipment as required to accomplish quality responsibilities.
  • Develops and documents test plan protocols, test procedures, and test reports.
  • Perform tests according to various protocol requirements.
  • Lead completion of risk management and risk analysis including FMEA.
  • Devise design verification and design validation plans for products based on performance specifications and risk analysis
  • Analyze and communicate conformance to specifications and standards.
  • Conducts technical and statistical investigations concerning compliance to specification and optimization of design relevant to specification.
  • Support completion of in vitro testing including applicable animal studies.
  • Aide in definition of supplier quality specifications, sampling plans, and vendor qualification.
  • Assist in specifications and testing of sterilization methods.
  • Lead system and product continuous improvement teams.
  • Reviews Engineering Change Orders, as required.
  • Perform other duties and responsibilities as assigned by senior management.


Posted: September 24, 2019, 12:18 pm
Category : Software Engineer
Job Type : Contract
Id : 7752
Region : Twin Cities

Seeking a Software Engineer to perform Incident Management and Root Cause Analysis of software anomalies. Provide technical support and guidance through Tier 2 support and work with cross functional teams to resolve Tier 3 issues. You will develop and apply standard methods of incident management and troubleshooting as well as develop and test software to automate detection of anomalies and enhance system recovery. You will recommend procedures and controls for problem prevention. Maintain knowledge database and call tracking database to enhance quality of problem resolutions.

Position Responsibilities:

  • Read and analyze system requirements
  • Identify root cause of anomalies
  • Use SQL skills to evaluate data and determine if data recovery is necessary
  • Develop strategies to automate the detection of anomalies and develop method of auto correction
  • Establish and maintain traceability from software requirements to verification test design and implementation.
  • Participate in the technical review of peer development and test code
  • Assist development team on debugging and solving issues discovered during support activities
  • Prepare, review, submit, and maintain project/product documentation
  • Work in a team setting, sharing information and assisting others with incidents
  • Design and execution of tests using automated and manual test tools as part of the development process

Position Requirements:

  • Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience.

Nice to Have:

  • Experience in SQL
  • 2+ years work experience with Incident Management and application support
  • 2+ years of IT or Computer Science experience
  • Experience with ServiceNow Incident Management tool
  • Experience in supporting software applications in the Cloud
  • ITIL Foundation Certification


Posted: September 24, 2019, 7:59 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7751
Region : Twin Cities

The Senior Quality Engineer. develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.



Posted: September 24, 2019, 7:42 am
Category : BioMedical Engineer
Job Type : Contract
Id : 7750
Region : Twin Cities

Seeking an experienced, high caliber Development Quality Risk Management Engineer to assure that new or modified products conform to standards and establish compliance with the quality system. This position will be responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Summary:

  • Ability to lead, coordinate, and execute, in a timely manner, Risk Management Documentation yearly updates
  • May make significant departures from traditional approaches to develop and implement solutions
  • Works closely with R&D/Regulatory/Clinical/Quality Engineering to establish and ensure risk management file compliance with the quality system
  • Ability to act on their own desire to make a difference, partner with others and put ideas into action
  • Actively engaged in a work culture that is team oriented, fast paced, accountable and progressive

Main Responsibilities:

  • Evaluates risk management file documentation to ensure compliance with company standards and governmental regulatory requirements
  • Ensures company's adherence to the established Quality System, ISO standards, and EU MDD/MDR standards
  • Assists in completion of Risk Management activities, including Hazard Analysis, Use & Design FMEA, Risk Management Plans and Reports
  • Analyze field performance data and provide assessment of clinical harm/failure modes
  • Works with R&D engineering to devise applicable Design Verification and Validation reports for Risk Mitigation
  • Analyzes prints to devise risk mitigation for product FMEAs
  • Ability to analyze IFUs and provide flowcharts of procedure
  • Works with Clinical and R&D to determine accurate harms for associated hazards (in relation to FMEAs)
  • Ability to assess new hazards and mitigation associated with design changes
  • Technical writing Individual and Overall Benefit-Risk statements
  • Strong aptitude with Excel (Pivot Tables, Macros, etc.) desired, but not required

Minimum Requirements:

  • Bachelor level degree in Engineering or other Technical Field
  • 1-5 years’ experience
  • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
  • Working knowledge of FDA 21 CFR Part 820, GMP, and ISO 14971
  • Experience supporting product design and development
  • Solid communication and interpersonal skills
  • Strong verbal communications and written communications with ability to effectively communicate at multiple levels in the Organization
  • Advanced computer skills (Micosoft Excel Macros), including statistical/data analysis and report writing skills
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to leverage and/or engage others to accomplish projects
  • Multitasks, prioritizes and meets deadlines in timely manner
  • Strong organizational and follow-up skills, as well as attention to detail
  • Prior medical device experience preferred
  • Experience working in a broader enterprise/cross-division business unit model preferred


Posted: September 23, 2019, 9:35 am
Category : Technicians
Job Type : Contract
Id : 7745
Region : Twin Cities

Seeking a Principal Technician with Medical Device experience. In the short term, project would be supporting testing of guidewires on a sustaining medical device. Then, the experienced Technician will be working on a new product development project including vascular catheter development, injection molding

  • Specification testing support
  • Test method fixture development
  • Design characterization, verification, and validation testing of the mechanical properties of the delivery system (including flexibility, tensile, kink, and simulated use testing)
  • Documentation support of the testing
  • Minimum 4 years of relevant experience
  • Vocational or technical education preferred, but not required


Posted: September 18, 2019, 1:18 pm
Category : Quality/Regulatory
Job Type : Contract
Id : 7744
Region : Twin Cities

Seeking a Senior Reliability Engineer to apply system thinking in planning and executing design for reliability and design assurance methodologies and risk management for products or systems. This position will conduct evaluation of systems activities including requirements, design, development, documentation, integration, test, verification and validation; Provide input to design/process development, design controls, test method development, and design validation for achieving required levels of product reliability; Completes risk assessments, including Hazard Analysis (HAs), to evaluate impact of potential issues to patient safety and product performance; Performs, facilitates and participates in risk management, risk analysis, fault tree analysis, failure trending and failure analysis. This Reliability Engineer will represent the organization as technical contact for reliability, design assurance, and/or safety and other technical projects and/or programs; create documentation in compliance with applicable procedures to meet project deliverables.

MINIMUM REQUIREMENTS:

  • Demonstrated ability to work effectively and collaboratively in a team environment and build strong working relationships
  • Ability to work in a fast-paced environment; ability to work well under pressure and maintain positive, enthusiastic attitude
  • Strong attention to detail and accuracy
  • Excellent organization skills; ability to successfully balance and prioritize multiple ongoing projects/tasks
  • Strong analytical skills and the ability to solve problems through analytical reasoning.
  • Ability to lead cross-functional teams and drive discussion and decision-making. This includes facilitation, consensus building and conflict resolution.
  • Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience), including presentation skills
  • High degree of initiative and self-motivation.

NICE TO HAVE:

  • Strong preference given to candidates with Software Reliability Engineering experience
  • Experience in medical devices or other highly regulated industry
  • Experience in quality, reliability, design assurance, safety, or systems engineering
  • Experience with and knowledge of medical device standards including ISO 13485, and ISO 14971 (risk mgmt.)
  • Design for Reliability and Manufacturability (DRM) certification
  • ASQ Certification in Quality or Reliability
  • Knowledge of therapy (clinical) performance, product function(s), and product use environments
  • Knowledge of reliability tools and practices that effectively support requirements, design, integration and verification, validation, and prediction
  • Knowledge/experience working with CAPAs, non-conformances, and other post-market issue escalation
  • Excellent problem-solving skills, including demonstrated application of structured problem-solving methods and tools
  • Strong statistics background
  • Proficient in word processing, spreadsheets, and managing electronic data files


Posted: September 18, 2019, 12:09 pm
Category : Software Engineering
Job Type : Contract
Id : 7738
Region : Twin Cities

In this exciting role as a Senior Software Reliability Engineer you will have responsibility for ensuring company products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.  This position provides software reliability engineering on new product development teams for R&D. The candidate will be a key player in cross-functional teams and serve as a technical representative for reliability, safety and quality functions.  As part of R&D project teams, the Senior SW Reliability Engineer will define, contribute, and execute the overall reliability related programs. This position will work with multidisciplinary teams and provide leadership for Design for Reliability (DfR), guidance to technical issues, engagement in design and risk reviews, and contribute to development activities.

A Day in the Life:

  • Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
  • Ensures that corrective measures meet acceptable reliability standards.
  • May develop mathematical models to identify units, batches or processes posing excessive failure risks.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability.
  • May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.
  • Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
  • Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • Completes risk analysis studies of new design and processes.
  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.

 

Minimum Requirements:  Bachelor's degree and 4+ years relevant experience OR Masters degree with 2+ Years experience.

 

Preferred Qualifications:

  • Advanced degree in Engineering or Science
  • Proven understanding of reliability engineering principles
  • Strong understanding of and experience in the application of statistics, including experience with Minitab
  • Experience in a highly-regulated industry, preferably implantable medical devices
  • Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc.
  • Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA)
  • Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms
  • IBHRE Certified EP Specialist (Allied Professional) and/or CRE Certified
  • Exposure to or experience working in or with Design, Quality, Regulatory, Clinical and/or Manufacturing
  • Knowledge of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices
  • Medical Safety Engineering/Risk Management experience
  • Medical training, medical field experience, and/or IBHRE certification

 

Posted: September 16, 2019, 10:01 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7736
Region : Twin Cities

The Design Assurance Engineer provides technical engineering support to post market / sustaining engineering teams and new product development in the medical device industry. This individual will be expected to apply his/her knowledge of design control principles and quality engineering techniques to post market / sustaining and development efforts, as a member of one or more cross-functional development team(s). In parallel, this person shall also ensure the products are developed in accordance with applicable industry standards, regulatory requirements and customer requirements.

Major Responsibilities:

  • Supports post market / sustaining engineering efforts on commercialized products
  • Create and maintain risk management deliverables (Risk Management Plans/Reports, FMECAs, Post-Market Surveillance Reports, Periodic Safety Update Report, Risk Management Plans/Reports) in compliance to internal and external requirements including new EU MDR requirements.
  • Supports Regulatory Affairs by providing quality input for Clinical Evaluation Reports, Technical Documentation, and notified body submissions.
  • Participates in corrective/preventive action teams to resolve systemic issues. Partners with cross-functional peers to resolve product performance issues (NCRs, CAPAs, deviations, manufacturing process problems etc.) and to assess impact on device quality and product availability.
  • Partners with multiple manufacturing sites and external suppliers to review and assess any design or process changes that may impact the product specifications or overall performance.
  • Participates in product development process to include design verification, design validation, process validation and other activities as needed.

Position Qualifications:

  • BS in engineering, science or technical field.
  • 1-5 years of experience in Quality Engineering in medical device industry
  • Experience in related areas, e.g. R&D or Manufacturing may also be applicable if experience includes work responsibilities listed above

Desirable Qualifications:

  • Risk Management background – preferably medical device
  • Technical writing experience
  • 1-3 years of experience in Quality Assurance, including Quality systems, standards, metrics, and tools desirable
  • Experience with Canadian Medical Device Regulation (CMDR); EU Medical Device Directive (EU MDD 93/42 EEC), EU Medical Device Regulation, ISO 13485, and ISO 14971 a plus.


Posted: September 9, 2019, 9:38 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7734
Region : Twin Cities

Seeking a Senior Quality Engineer to support New Product Development Process Development and Qualification of Finished Medical Devices and their components from external suppliers. Heavy involvement in Process Development including IQ's, OQ's, PQ's, TMV, pFMEA's and Control Plans.

Position Responsibilities:

  • Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
  • Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
  • Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
  • Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
  • Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
  • Communicates with senior internal and external customers and vendors.
  • May have practical knowledge of project management.

Position Requirements:

  • Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


Posted: September 6, 2019, 7:38 am
Category : Reliability Engineer
Job Type : Contract
Id : 7729
Region : Twin Cities

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

  • Investigates problems with company medical devices in the field. Responsible for manufacturing changes required to improve deployed products and documentation of these changes.
  • Ensures that company medical devices adhere to global safety requirements and EU/MDR standards.
  • Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
  • Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • Completes risk analysis studies of new design and processes.
  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
  • Ensures that corrective measures meet acceptable reliability standards.
  • Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
  • May develop mathematical models to identify units, batches or processes posing excessive failure risks.
  • As necessary, proposes changes in design or formulation to improve system and/or process reliability.
  • May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.

Position Requirements:

  • Bachelors Degree
  • 0-10 years experience, Internships OK. Ideally 3-5 years experience.
  • Medical Device experience
  • Cardiac experience is helpful
  • EU/MDR standards compliance experience is helpful



Posted: September 3, 2019, 8:52 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7730
Region : Twin Cities

Seeking an Associate Quality Engineer to act under the supervision of Sr. Quality System Manager on multiple assignments of limited scope and complexity.

 

Position Responsibilities:

  • Defines current versions of standards and generates product standard list (PSL) in support of manufacturing products.
  • Participates in PSL updates and reviews.
  • Creates and collaborate on change orders to release PSL
  • Ensures compliance with GMP's and internal requirements.
  • Analyzes the reviews and feedback of the PSL and update them.
  • Participates in Standards Governance Boards.
  • Other duties as assigned.

 

Position Requirements:

  • Entry level individual contributor on a project or work team
  • Requires a Bachelors of Science Degree, 0 -3 years of experience required.
  • Knowledge of Microsoft Office is required.


Posted: September 3, 2019, 6:55 am
Category : Controls Engineer
Job Type : Contract
Id : 7725
Region : Twin Cities

Seeking a Controls Engineer to develop control system design and application of various technologies including: multi-axis motion control, image processing, vision-guided robotics, industrial instrumentation & automatic control. This position will provide technical leadership in a team-oriented work environment, interface with customers on technical projects, system programming PLC/motion/vision, startup/commissioning of machine control systems.

Position Requirements:

  • BS or MS in Mechanical or Electrical Engineering with control system emphasis (min 3.2 GPA) and relevant intern or co-op experience.
  • Strong electromechanical aptitude.
  • Motion control/Robotics experience (Delta Tau, Adept, Yamaha, Epson).
  • PLC/PC programming experience (Allen-Bradley, GE Fanuc, etc.).
  • Vision experience (Cognex, DVT, Adept).
  • Solid organizational skills.
  • Strong desire to work in a fast-paced, entrepreneurial environment.
  • Ability to consistently deliver on commitments.


Posted: August 28, 2019, 12:46 pm
Category : Mechanical Engineer
Job Type : Contract
Id : 7724
Region : Twin Cities

Seeking a Senior Mechanical Design Engineer for the following duties:

  • 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: August 28, 2019, 12:44 pm
Category : Electrical Engineer
Job Type : Contract
Id : 7721
Region : Twin Cities

Seeking a Principal Electrical Engineer to provide electrical engineering technical leadership to influence and improve the manufacture and development of hand held and desktop medical instrumentation products. This position evaluates existing products and provides solutions that improve manufacturability, reduce cost, and increase reliability. The Engineer Leads cross functional project teams including members from Product Development, Manufacturing, Marketing, Contract Manufacturing Engineering, Reliability, and Regulatory functions to identify, implement, and qualify revised medical products. Also, acts as a liaison with external vendors to insure continuity of product supply. Ability to multi-task in a fast-paced environment is essential.

Position Responsibilities:

  • Provide both the technical leadership and management for both electrical and mechanical projects that expand the capabilities of existing product and system solutions, managing the deliverables to ensure that high quality product is developed on schedule and budget.
  • Develop and implement technical solutions that maintain a continuity of product availability and satisfy broader organizational strategies.
  • Design, simulate, and test analog and digital circuits for the development of improved solutions and evaluation of returned product.
  • Takes work direction both from management and engineering staff and provides work direction and mentoring to other engineers and technicians at various levels within the function.
  • Insures collaboration among cross functional team members throughout the development and support of a product.
  • Represents the organization as a technical contact for product inquiries from field support personnel, regulatory agencies, and the medical community.
  • Provides technical support to Design, Operations, Manufacturing, Reliability, Contract Manufacturing Engineering, and Service Departments.
  • Review, approve, document, and implement design changes.
  • Responsibilities will range from being very hands on at times, to giving direction and reporting out to a very high-level audience.
  • Typical issues are reactive and are often urgent, so priorities change frequently, and issues must be resolved quickly to assure quality and continuity of supply.

Required Qualifications:

  • 15+ years of industry experience
  • BS or MS in Electrical Engineering
  • Up-to-date (within the last 5 years) hands-on experience with evolving technology such as USB, Bluetooth, mobile (cellular) technology, and WiFi.
  • Years of experience in the development or support of medical products within the last 15 years.
  • Skills include analog/digital circuit design and troubleshooting, laboratory practices, circuit simulation, product testing, and design of experiments
  • Experience in a technical leadership position.
  • Demonstrated problem solving skills
  • Strong written communication skills

Desired Qualifications:

  • Demonstrated influencing skills.
  • Experience in manufacturing or post market support
  • General understanding of how to interpret and apply industry recognized standards, especially for medical electronic products.
  • Strong verbal skills
  • Experience with quick turn assignments


Posted: August 28, 2019, 8:27 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7717
Region : Twin Cities

The Quality Engineer will apply and maintain quality standards in a fast-paced medical device testing environment in collaboration with laboratory and engineering functions.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Review, modify and evaluate laboratory protocols, reports, procedures and other quality records
  • Collaborate with cross-functional teams, such as laboratory, manufacturing, design, reliability, and regulatory affairs, to ensure quality standards are in place and due dates are met
  • Support implementation of methods and procedures for laboratory inspection, testing and evaluation of medical devices, components and raw materials, as well as records and procedures for laboratory equipment
  • Verify and assist with laboratory investigations, nonconformance reporting and CAPA activities
  • Ensure that corrective measures meet acceptable quality standards and that documentation is compliant with requirements
  • Stay informed about changes to internal and external quality regulations
  • Exercise a positive team spirit and be responsive to all inquiries to support the Company Mission

QUALIFICATION REQUIREMENTS:

  • Four-year degree in a technical field such as, but not limited to, engineering, chemistry or biology
  • 2-5 years of experience in quality engineering
  • 1-2 years of experience in an FDA regulated environment
  • An established and productive individual contributor who works independently with general supervision on larger, moderately complex projects and assignments
  • Knowledge of laboratory cGMP/GDP requirements and applicable regulatory guidelines
  • Sets objectives for own job area to meet the objectives of projects and assignments and contributes to the completion of project milestones
  • Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area
  • Communicates primarily and frequently with internal contacts; external interactions are less complex or problem solving in nature


Posted: August 26, 2019, 7:13 am
Category : Controls Engineer
Job Type : Permanent
Id : 7711
Region : Twin Cities

Seeking a Principal Automation Engineer to provide concept development, specification (URS authoring), and quoting of automation in support of new opportunities at the Global Innovation and Development (GID) Center or the US manufacturing facilities.

 

Position Responsibilities:

  • Partner with the US supply chain organization to manage the US automation Approved Vendor List (AVL), including performing competency assessments for sources on the AVL to match vendors with suitable opportunities.
  • Serve as the design for assembly / automation Subject Matter Expert for GID development programs
  • Provide project-based technical assistance, as needed, serving as a project team member.
  • Lead specification (URS authoring), sourcing, project management, and/or acceptance (FAT/SAT) of automation projects to support US manufacturing facilities or GID.
  • Work with manufacturing facility engineering & management to identify opportunities for automation and robotics to reduce cost and improve quality, with a focus on flexible automation that can be used across multiple customer programs.
  • Demonstrated flexibility to manage multiple projects and interface with teams at multiple facilities, including temporary assignments at facilities other than the assigned home base for this position.
  • Lead company-wide Automation Council, focused on component standardization, education and exploration of new technologies, and development of automation best practices.
  • Actively participate in continual improvement, corrective action and customer satisfaction.

 

Required Qualifications:

  • Bachelor degree in mechanical engineering, electrical engineering, manufacturing engineering, industrial technology
  • Minimum five (5) years proven experience in automated machine design or assembly
  • Experience with SolidWorks or other mechanical CAD system

 

Posted: August 16, 2019, 9:08 am
Category : Packaging Engineer
Job Type : Permanent
Id : 7712
Region : Twin Cities

Seeking a Packaging and Sterilization Engineer to direct medical packaging programs through development. This position is a resource to medical production facilities to support plant efforts.

 

Essential Functions:

  • Partner with management on setting goals for business implementation and operational effectiveness.
  • Interpret and negotiate packaging, labeling and sterilization requirements to meet customer needs.
  • Act as a packaging resource to partner with Sales, Cost Estimators, Purchasing and Business Development on quoting and sourcing programs with packaging materials and /or services and trade show support.
  • Set top-level project implementation deliverables and dates and manage the execution.
  • Identify software, hardware and equipment needs for packaging and labeling operation.
  • Develop manufacturing line layout plans and determine the space needed for device packaging and labeling.
  • Identify and monitor the supporting resources required for various stages of business implementation, on-going support of the packaging operations, and drive task-level management.
  • Monitor and justify packaging resource requirements.
  • Develop and manage project schedule(s) required to implement packaging components and equipment.
  • Partner with Project Engineers and Program Managers to successfully transition programs from development to production.
  • Coordinate the transfer of contracted packaging/assembly jobs to facilities.
  • Remain up-to-date on the latest trends and technologies in the packaging industry.
  • Instill a mindset that will proactively cause those involved in the business to put all GMP regulations at the forefront of their day-to-day activities.
  • Build partnerships with suppliers and packaging contractors.
  • Support AQP Process Road Map and checklist for assembly/packaging and sterilization programs.
  • Partner with Regulatory/Validation personnel related to Sterilization Management.
  • Extended travel to other facilities may be required to support business needs.
  • Provide backup to the Project Engineering team as required based on project load.
  • Coordinate, direct and lead engineering efforts to ensure optimum engineering of projects/programs to meet customer and manufacturing requirements.
  • Maintain cost control and profitability through interaction with the accounting group, sales and our customers.
  • Facilitate communication between customer, sales, engineering functions, outside vendors, manufacturing and multi-facility groups.

 

Required Qualifications :

  • Bachelor's degree in Packaging Engineering or closely related field
  • 2 + years of product packaging experience preferred
  • Familiar with current regulatory trends and packaging / sterilization requirements preferred
  • Experience in medical product sterilization preferred

 

Skills and Abilities:

  • Excellent written, verbal and presentation communication skills
  • Ability to coordinate multiple projects at one time
  • Ability to work with internal and external customers in a productive and team approach


Posted: August 16, 2019, 9:07 am
Category : Mechanical Engineer
Job Type : Contract
Id : 7657
Region : Twin Cities

Looking for a Mechanical Engineer to design medical devices to comply with industry methodologies and standards.  This candidate will define requirements, technologies, and methodologies for individual projects.  Research and analyze data such as experimental data, customer design proposals, specifications, and documentation.  Direct and coordinate actions from product conception through design transfer to ensure products and systems conform to engineering design, standards and customer specifications.  Resolve technical issues and problems.  Effectively communicate their work and status.  Delegate work and leverage engineering technicians and designers.

 

Essential Duties and Responsibilities

  • Applies principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials.
  • Designs medical products and confirms correctness using methodologies and tools such as FEA, GD&T, CFD, etc.
  • Evaluates mechanical and electromechanical systems and products by designing and conducting research programs.
  • Leads and completes medical standard document deliverables.
  • Identifies and efficiently resolves technical problems and issues.
  • Leads and communicates to a client for small scale programs.
  • Researches and analyzes experimental data to understand design issues and set a direction for issue resolution.
  • Prepares product reports by collecting, analyzing, and summarizing information and trends.
  • Delegates and sets work direction for technicians and designers.
  • Works with suppliers and manufacturing facilities to design for manufacturability.

 

Education/Experience:

  • Bachelor's degree in Mechanical Engineering or equivalent
  • Minimum 3+ years of experience in new product development.
  • Direct experience with the product development process ranging from requirements development, prototyping, verification and product release is required.
  • Experience in medical device design or other regulated industries preferred.
  • Must have demonstrated experience working on electromechanical systems.
  • Prefer experience with IEC 60601-1 and with ISO 14971 Risk Management for Medical Devices.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. 
  • Ability to write reports, business correspondence, and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.

 



Posted: May 14, 2019, 11:46 am
Category : Test Engr - Technical
Job Type : Permanent
Id : 7626
Region : Twin Cities

Seeking a Senior Software Test Engineer to provide end to end development of TestStand/LabVIEW solutions for custom functional test systems including, writing requirements; test system development and integration; acceptance testing and technical support.

Major Areas of Accountability:

  • Develop software test system requirements
  • Design software solutions that satisfy test system requirements
  • Lead or participate in design review meetings
  • Collaborate with other engineering disciplines to ensure effective overall system design
  • Provide technical leadership on projects involving multiple engineers, including leading the overall design approach partitioning work among the team and sequencing detailed design activities to support the overall project schedule
  • Support the sales process by providing technical expertise in customer proposals
  • Provides effective communication with project team members, including project status, risks and suggestions to project leadership
  • Collaborate with customers as needed to accomplish customer goals

Education and Experience:

  • Bachelor’s Degree in Electrical Engineering, Computer Science or equivalent experience in a test engineering environment
  • 5 – 10 years of work experience using TestStand and LabVIEW
  • CLD or CLA is preferred
  • Ability to design TestStand or LabVIEW architectures based on system requirements
  • Application software development skills in Microsoft Visual Studio (VB.NET/C#). C/C++ experience a plus
  • Analyze existing test solution (electrical/software) and understand the design for maintenance or updating/upgrading test software
  • Solid analytical skills; able to resolve technical problems with innovative solutions
  • Proven ability to manage working on multiple projects at a time while paying strict attention to detail
  • Proficiency with Microsoft Office Suite
  • Effective verbal and written communication skills
  • Capacity to deal with a high workload and deadline pressure
  • Requires a strong initiative, proactive nature and a sense of urgency
  • Ability to travel 0% - 10% to client locations for meetings and/or system installations
  • Ability to work extended hours as necessary to meet deadlines
  • Must be able to perform in a team environment with good interpersonal skills with commitment to the highest quality achievable
  • Maintains confidentiality and security of intellectual property (ITAR, Prototype)


Posted: April 4, 2019, 12:07 pm
Category : Controls Engineer
Job Type : Permanent
Id : 7556
Region : Twin Cities

Seeking a Systems Engineer to develop control system design and application of various technologies including: multi-axis motion control, image processing, vision-guided robotics, industrial instrumentation & automatic control. This position will provide technical leadership in a team-oriented work environment, interface with customers on technical projects, system programming PLC/motion/vision, startup/commissioning of machine control systems.

Requirements

  • BS or MS in Mechanical or Electrical Engineering with control system emphasis (min 3.2 GPA) and relevant intern or co-op experience.
  • Strong electromechanical aptitude.
  • Motion control/Robotics experience (Delta Tau, Adept, Yamaha, Epson).
  • PLC/PC programming experience (Allen-Bradley, GE Fanuc, etc.).
  • Vision experience (Cognex, DVT, Adept).
  • Solid organizational skills.
  • Strong desire to work in a fast-paced, entrepreneurial environment.
  • Ability to consistently deliver on commitments.


Posted: December 6, 2018, 9:22 am
Category : Software Engineer
Job Type : Contract
Id : 7548
Region : Twin Cities

 

Essential Job Functions & Responsibilities:

  • Embedded firmware design and implementation
  • Support projects for new and existing customers. This will require theoretical analysis, simulation analysis, software/firmware implementation, code review, documentation, and hardware/software integration testing.
  • Support communication protocol development efforts: network security protocols, wireless mesh networking and network security
  • Support development in multiple operating systems:  Linux, FreeRTOS, bare metal, Windows, etc.
  • Coordinate and work collaboratively cross functionally as well as with other software development teams in the organization
  • Lead software efforts being self-directed as well as leading small software teams
  • Mentor junior engineers in current trends and best practices
  • Provide outstanding documentation of software designs
  • Assist with certification testing
  • Coordinate software releases with internal and external stakeholders
  • Participate in appropriate training and development programs to maintain and enhance job-related skills

 

Required Qualifications:

  • Minimum: BS or MS in Computer Engineering, Electrical Engineering or Computer Science
  • 10+ years of related experience
  • Direct experience in programming in C for real-time embedded systems
  • Significant experience working with 32-bit microcontrollers in a flash and RAM constrained system
  • Significant experience with microcontroller peripherals and interfaces: UART, SPI, ADC, PWM, Timers, etc.
  • Development experience with embedded Linux (layers below application) and RTOS/bare metal
  • Skilled in the use of test and debug equipment: oscilloscopes, logic analyzers, multi-meters, spectrum analyzers, etc.
  • Demonstrated ability to function self-directed in leading software engineering efforts
  • Demonstrated ability to lead a small team of software engineers, i.e. task planning/managing, mentoring, defining core architecture, etc.
  • Good communication and team skills, both externally and internally
  • Solid debugging, troubleshooting, and problem solving ability
  • Eagerness to collaborate with team members and coworkers within the organization
  • Solid experience in delivering quality documentation (Requirements, Design Doc's, test plans)
  • Experience working through all phases of software development (Concept, architecture, development, test, release to manufacturing)

 

Preferred Qualifications:

  • Experience in developing Linux Kernel drivers, and low level Linux protocols
  • Experience in developing in real-time operating systems
  • Experience with RF communication
  • Experience with RF protocols at the PHY/MAC/NWK layers such as 802.15.4, zigbee, BLE, or Wi-Fi
  • Experience with networking protocols
  • Experience with a revision control system, GIT is preferred
  • Python experience
  • Experience with unit testing


Posted: November 20, 2018, 11:57 am
Category : Sales
Job Type : Permanent
Id : 7488
Region : Twin Cities

Development Resource Group is a fast-paced, well-established engineering staffing firm seeking a motivated and energetic individual to join our growing recruiting team. Development Resource Group has been supplying contract and direct hire technical staffing since 1986 specializing in Medical Device, Engineering, R&D, and Product Development.

DRG specializes in placement of hardware, software, and mechanical engineering personnel on projects with many high tech product development companies in the Twin Cities. Our engineers are responsible for design, programming, and testing of products for medical device, electronic products, and automation systems.

The Technical Recruiter must have excellent communication skills, a high level of computer system knowledge, and preferably direct experience in sourcing, interviewing, and placement of high-level product development engineers.

We are seeking an individual to manage the full recruiting lifecycle: sourcing, screening, interviewing, reference checking, and negotiating employment terms. The candidate will be well versed in all aspects of professional recruiting, including networking and the recent trends in hiring.

Ideal candidates will be skilled in the use of applicant tracking systems and be self-sufficient in navigating and administering the applicant flow process.

Prefer BS degree, with proven track record of success in the staffing industry.

We offer excellent earning potential, a competitive benefit package, and an opportunity to be successful in the fast-paced, growing technical staffing industry.


 

Posted: September 6, 2018, 9:34 am
Category : Sales
Job Type : Permanent
Id : 7487
Region : Twin Cities

Development Resource Group is a growing Technical Staffing firm located in Mounds View, MN. Since 1986, DRG has been assisting clients in locating experienced engineers for project-based work on a temporary, contract-to-hire, or permanent basis. We specialize in placement of hardware, software, and mechanical engineering personnel with a strong base of high tech product development companies in the Twin Cities. Our engineers are responsible for design, programming, and testing for medical device products, electronic products, control products and automation systems.

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, 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.

We offer an enjoyable working environment with a proven track record in our industry, excellent earning potential, a very competitive benefits package and an opportunity to be successful in the fast-paced, growing technical staffing profession.



Posted: September 6, 2018, 8:20 am
Category : Technician - Medical Equipment
Job Type : Contract
Id : 7319
Region : Twin Cities

Immediate opportunity for an Equipment / Controls Automation Technician to support design, start-up, troubleshooting, and validation of automated equipment for medical device product manufacturing. This position will support Controls Engineers in machine design development, including Autocad Electrical design and documentation of control panels, schematics, and mechanical components, updating / programming PLC and HMI software, support repeat equipment builds, and troubleshooting and solving hardware and software (PLC, HMI, Vision) issues.

Requirements include:

  • 2 year Electrical / Automation Tech degree, with
  • Training and experience in design, programming, and troubleshooting of industrial control systems.
  • Requires proficiency with Autocad Electrical Cad, and training in troubleshooting PLC and HMI systems, robotics, machine vision, and controls instrumentation.
  • Will consider entry level candidate with solid training in automated systems, or technician with up to several years of experience.


Posted: April 2, 2018, 8:52 am
Category : Controls Engineer
Job Type : Contract
Id : 7297
Region : Twin Cities

 

Seeking a Machine Vision Software Engineer / Electrical Engineer / Software Engineer needed to develop and support existing machine vision inspection systems and custom automated control systems used in the development and production of medical devices. Will work within equipment/software engineering group to design machine vision systems, including concept, plans, programming, and troubleshooting for complex manufacturing and test equipment.

 

Requirements:

  • Bachelor of Science (CS or EE)
  • Manager is open to all levels of experience with automated equipment development, including some hands-on vision system knowledge.
  • Prefer experience with .NET and C++ programming, Allen Bradley PLC's and understanding of automated equipment design.
  • Prefer experience with Cognex Vision system development.
  • Exposure to robotic systems a plus.

 

Job Responsibilities:

  • Investigate machine vision software to identify opportunities to increase yields and/or quality of the vision system.
  • Determine root cause with regard to machine vision inspection issues.
  • Update machine vision software for enhancements and bug fixes of existing systems.
  • Investigate machine vision lighting solutions to enhance existing inspection systems.
  • Collect and analyze inspection results to prove robustness of vision system changes.
  • Integrate machine vision system into a PC or PLC based system.
  • Troubleshoot machine vision and controls systems using pneumatic and electrical schematics.
  • Develop/Update departmental standards.
  • Create supporting design documentation.
  • Make software and hardware modifications to existing automated controls equipment.
  • Follow departmental procedures and processes when updating and developing new systems.
  • Participate on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for electrical/software designs.
  • Communicate costs and project status to project lead.
  • Creates electrical/software designs utilizing the departments' standard development tools and procedures.


Posted: March 15, 2018, 12:25 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