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Development Resource Group

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

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 : Technician - R&D
Job Type : Contract
Id : 7176
Region : Twin Cities

We're looking for a Dialysis R&D Test Technician to provide Engineering test and equipment support for development of hemodialysis-related systems.

Job Description:

  • Assemble, test, debug and trouble shoot electro-mechanical test equipment. Interface instruments and actuators to prototypes and test systems
  • Independently set up test equipment and efficiently execute manual and automated tests.
  • 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.
  • Accurately and thoroughly document test results to meet quality system requirements.
  • Follow applicable quality system procedures governing development of a medical device.

Job Qualifications:

  • Associate degree in a technical field such as electronics, mechanical technology, or software programming.
  • Minimum 2 years' experience in engineering test supporting new product development
  • Ability to fabricate circuits, and interface instruments and actuators to software controls
  • Familiarity with embedded systems and software. Familiarity with LabVIEW.
  • 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.
  • 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: December 7, 2017, 7:40 am
Category : Technicians
Job Type : Contract
Id : 7175
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: December 6, 2017, 11:13 am
Category : Reliability Engineer
Job Type : Contract
Id : 7174
Region : Twin Cities

Seeking a Senior Reliability Engineer to provide reliability engineering support of new product development programs and market released Medical Device products.

POSITION RESPONSIBILITIES:

  • Represents the quality function in product development teams/projects to include reviewing plans (quality plan, risk management plan) and requirements (safety, functionality, regulatory) to ensure provisions for quality are addressed & resolved prior to release
  • Works closely with R&D and the project team to develop review and approve appropriate verifications (DVT) for both new design and changes to released product.
  • Provides support guidance in the statistical analysis of data and technical support for technicians performing the testing; assuring the resolution of all issues raised by the testing.
  • Engages in reliability assessments in bench, lab, and/or clinical settings, producing full traceability of reliability assessment evidence to performance measures, metrics and requirements.
  • Develops reliability growth and verification test plans, accelerated testing methods, statistical data analysis methods and test equipment concepts to support product and subsystem reliability growth and evaluation.
  • Develops sterilization validation tests plans, ensure proper execution and review validation reports
  • Review and approve changes to designs/processes and assess impact on product and qualification status
  • Supports Materials Quality Engineering by providing reliability input in the evaluation of discrepant material and in the qualification of new material to assure that device reliability requirements are met.
  • Supports Regulatory Affairs by providing reliability input in the evaluation of MDRs and submissions of requests of approval to the FDA; investigating and evaluating product field problems--this includes preparing Health Hazard Analysis and working with Marketing, Product Development and Regulatory on field action plans.
  • Maintains expertise in international safety standards and serve as a resource to assist in the development of products that meet all international requirements.
  • Ensures team compliance of relevant safety regulations, QSRs, ISO Standards, CMDR, MDD, Quality Business System and Key Corporate Policies
  • May participate in sustaining engineering projects
  • Addresses assigned CAPA (corrective and preventive action) activities, ensuring that established timelines are met
  • Ensures technical documentation meets requirements of the regulation such as ISO 13485 and FDA CFR820

POSITION QUALIFICATIONS:

  • 5+ years in Reliability Engineering, Quality Assurance, Product Development, or manufacturing with a B.S. degree
  • 3+ years in Reliability Engineering, Quality Assurance, Product Development, or manufacturing with a master's degree in engineering
  • 2+ years of experience working with and providing direction for cross-functional teams.
  • 2+ years of experience working with medical device products and in the healthcare industry.
  • Ability to travel both domestically and internationally up to 20-30%

PREFERRED QUALIFICATIONS:

  • Experience in highly regulated industry, preferably Class III medical devices
  • Working knowledge of Agile documentation control system.
  • Proficient in word processing, spreadsheets, and managing electronic data files
  • Able to develop disposable medical devices as well as capital equipment.
  • Demonstrated ability to work in a matrix organization and positively influence strategies and outcomes.
  • Experience as a professional in development and/or systems position(s).
  • DRM Green Belt and/or Black Belt
  • Fluent in English and French
  • Knowledge of ASQ, ANSI, AAMI and ASTM standards and guidance documents.
  • Knowledge of GR&R, inspection qualification methods, sampling plans, inspection techniques, critical attributes, process validation, trending methods, environmental monitoring.
  • Knowledge and experience with statistical process control and other process monitoring methods and techniques.
  • Knowledge of heart anatomy and atrial fibrillation disease types a plus as is experience with RF ablation, cryo surgical or catheter based medical devices
  • Strong understanding of and experience in the application of statistics, including experience with Minitab.
  • Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)
  • Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact
  • Excellent problem solving skills, including demonstrated application of structured problem solving methods and tools


Posted: December 6, 2017, 11:05 am
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 : Quality Engineer - Medical Device
Job Type : Contract
Id : 7171
Region : Twin Cities

Seeking a Quality Engineer with a Medical Device background to assure materials used in Medical Device products are of high quality and reliability, and processes used by suppliers are capable and stable. This positions main focus will be to lead activities with suppliers to qualify supplier initiated process changes.

POSITION RESPONSIBILITIES:

  • This position supports a broad range of assigned Supplier Quality Engineering responsibilities which could include:
  • Leading supplier or process changes to components and finished medical devices
  • Supporting product continuation by assuring the quality of the components used in the manufacturing floor, and working supplier/component quality related issues to resolution.
  • Owning and leading CAPAs and sCAPAs for supplier caused issues
  • Review and resolve Material Review Board (MRB) issues through coordination of efforts across company operations and at incoming inspection.
  • Providing training and coaching to suppliers on company’s quality system requirements
  • Interface with company incoming inspection employees, including development and review of inspection procedures.
  • Perform test method validation on Receiving Inspection test methods.
  • 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.
  • Lead or participate in internal or supplier audits.
  • Travel 25%

BASIC QUALIFICATIONS:

  • Bachelors of Science Degree
  • 4-6 years of experience in quality, manufacturing or other related engineering field

PREFERRED QUALIFICATIONS:

  • Experience in an engineering support role in a manufacturing factory environment of metal forming, plastic forming/extrusion, chemical processing, foundry or wire coating.
  • Understanding of quality principles, procedures, methodologies, and basic statistics.
  • Knowledge of regulatory environments (i.e.: ISO, FDA-GMP, etc.)
  • Knowledge of statistical analysis techniques
  • Knowledge of DMAIC problem solving methodology


Posted: December 1, 2017, 2:29 pm
Category : Packaging Engineer
Job Type : Contract
Id : 7170
Region : Twin Cities

Seeking a Senior Packaging Engineer to collaborate on process continuous improvement and product commercialization cross-functional project teams. They are responsible for the design, development, and support of package systems and processes for sterile medical devices including components, assemblies, and end items. They are responsible for demonstrating high-level performance that delivers high-quality packaging on schedule, which meets customer, patient, and regulatory needs.

Position Responsibilities

  • Development of packaging components, and assemblies for sterile (sterilized by Ethylene Oxide, Steam, Gamma methods), medical products in support of new and existing products.
  • Provide technical recommendations and implement changes in the packaging process and materials.
  • As requested, collaborate with Packaging across company to identify and implement best practices, packages, and processes.
  • As requested, participate on cross-functional, cross-site project teams focusing on packaging, technology and process improvements.
  • Apply knowledge of FDA and ISO requirements related to packaging, ensuring robust package verification.
  • Experienced with IQ/OQ/PQ as part of packaging processes.
  • Draft technical documentation including package design testing protocols and reports for verification and release of package designs.
  • Manage shelf life (accelerated and real-time) and biocompatibility testing for new packaging material combinations.
  • Serve actively in the identification of suppliers, testing and approving materials, including liaison with vendors.
  • Ensure personal understanding of all quality policy/system items that are per assigned training curriculums. Follow all work/quality procedures to ensure quality system compliance.
  • Frequent collaboration with other departments and customers.
  • Self-directed and works under minimal supervision.
  • As requested, provide guidance/mentor Associate and Package Engineers with the Packaging Development organization.

Basic Qualifications:

  • Bachelor of Science in Packaging with 5+ years medical device packaging experience (or relevant medical device experience outside of packaging).

Preferred Qualifications

  • Experience working with ISO, ASTM, and standards related to packaging.
  • Working knowledge of project management methodologies.
  • Demonstrated initiative; results oriented; willingness and ability to institute change.
  • Process orientation and strong interest in continuous improvement.
  • Excellent communication (written and verbal) skills.
  • Effective decision-making skills - ability to negotiate and balance decisions and priorities across needs of multiple stakeholders. Makes timely decisions in the face of risk and uncertainty.
  • Medical device industry experience.
  • Demonstrated strong analytical skills and judgement.


Posted: December 1, 2017, 7:58 am
Category : Quality Engineering
Job Type : Contract
Id : 7169
Region : Twin Cities

Looking for a Senior/Principle Quality Engineer to be responsible for implementing, maintaining and improving the company's Quality Management System. Specifically review and revise, as needed, QMS policies and procedures to ensure the work conducted conforms to established corporate standards and industry regulations/standards. This position will be instrumental in contributing to defining the direction and plans for process improvement and ensuring the site is audit ready.

Must be comfortable coaching all employees on the Quality Management System and working professionally with others to reach understanding and agreement as necessary. This individual must be comfortable working autonomously in that much of their work will be completed with limited oversight from their manager.

POSITION RESPONSIBIITIES:

  • Quality System Management: Create and revise standard operating procedures as needed, gap analysis against Group and Enterprise requirements and regulations, including updates to SOP web portal and employee training. Ensure local team is following procedures and the QMS is operating effectively. Create, update and/or manage Quality Metrics. Assist with Management Review meeting preparation. Function as the site key compliance contact. Ensure the QMS is understood and followed by all team members.
  • Training: Responsible for preparing training matrices for the group and ensuring all members have their training assigned.
  • Experience in Supplier Quality: Assist in the management of the approved supplier list. Work with team to ensure supplier qualification requirements are being followed by reviewing supplier assessments, quality agreements, and initial part qualification and supplier risk assessment documentation as required by group/enterprise policies and QMS. Visit supplier as necessary to ensure drawings and specifications are understood.

POSITION QUALIFICATIONS:

  • Bachelor's Degree in engineering or technical discipline
  • 5- 10 years' experience in Quality compliance or Quality Management Systems with a minimum of 3+ years of the above mentioned experience in medical device and/or pharma industries.

PREFERRED QUALIFICATIONS:

  • Prior experience with ISO 13485 and U.S. 21 CFR 820 regulations for medical devices.
  • QMS auditor certification or previous auditing experience.
  • Strong written, verbal, and interpersonal communication skills
  • Strong computer skills : MS Office products and content management / quality systems-specific High attention to detail and accuracy.


Posted: December 1, 2017, 7:11 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7168
Region : Twin Cities

Looking for an experienced Manufacturing Engineer to design and plan layouts for such activities as machining, metal forming, plastics processing, welding and brazing, assembly, and materials handling. Adapt machine or equipment design to factory and production conditions. Design arrangements of machines within plant facilities to ensure most efficient and productive layout. Design sequence of operations and specify procedures for the fabrication of tools and equipment and other functions that affect product performance. May incorporate inspection and test requirements into the production plan. Inspect performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develop manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provide guidance to Engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.

POSITION RESPONSIBILITIES:

  • Manage technical aspects of product and process transition to manufacturing partners.
  • Ensure manufacturing processes adequately demonstrate specified process control capabilities.
  • Provide technical support and guidance to Manufacturer for engineering issues.
  • Conduct, coordinate and aid in formal Process Validations including protocol development and execution.
  • Manage all technical aspects of the ECO process into the Manufacturing organization.
  • Manage localization activities with Manufacturing and Sustaining Engineering.
  • Ensure new processes have adequately demonstrated specified process and test control capabilities, through being the Champion for PFMEA, DFM, DFT, DFSS, CAPA and NCR.
  • Specify and procure capital in the support of manufacturing and test processes.
  • Candidate must have the ability to work independently and be able to communicate effectively with team members.
  • Ability to meet at off hours to support of Manufacturers located across the globe with global time zone differences.
  • Work as a liaison with the Manufacturer and company to ensure design for manufacturing elements are incorporated to improve yield and reduce costs.
  • Provide guidance to Manufacturer in designs and evaluates new and existing fixtures and equipment, test methods, specifications, layouts, and standards supporting a Lean manufacturing environment.
  • Ensures adherence to product specifications, industry standards, and quality and regulatory procedures and requirements.
  • Support process verification and validation testing activities.
  • Assist with selection and qualification of new materials and suppliers

BASIC QUALIFICATIONS:

  • Bachelor’s degree in engineering or related technical field with a minimum of 4 years of related manufacturing experience, or Master’s degree in engineering or related field with a minimum of 2 years of related manufacturing experience

PREFERRED QUALIFICATIONS:

  • Experience with and effective application of Design for Inspectability, Validation Protocol and Report creation, SPC, Process Control Plans, MSA, Gauging applications, design, and construction, Sampling methodologies, Data Analysis.
  • Experience with and understanding of Machining, Molding, Grinding, Forming, Assembly, Welding, Finishing, Cleaning, Passivating, Anodizing, Shot Peening, Mass Media Operations, Coatings, EDM, Casting, Forging, Polishing
  • Average knowledge with Six Sigma and Lean Manufacturing.
  • Average knowledge with Design Verification and Validation activities
  • Excellent communication skills, both verbal and written.
  • Effective interaction with personnel at diverse positions within and outside of the organization.
  • Value other’s ideas and experience working in a team environment.
  • Able to work well with a diverse group of people both within the organization as well as with people outside the company.
  • Project Management experience or training. Work well under pressure, organized and able to attain results on several projects simultaneously.
  • Strong analytical and problem-solving skills and experience applying these skills to resolve technical problems in a manufacturing environment.
  • Well-informed and current on manufacturing methods and equipment.
  • A thorough understanding of the product development process and its needs
  • Results oriented and self-starter


Posted: November 29, 2017, 1:04 pm
Category : Quality Engineering
Job Type : Contract
Id : 7166
Region : Twin Cities

Looking for a talented and motivated Senior Design Quality Engineer / Reliability Engineer to join our Quality Organization. This individual will provide design quality and reliability support during the execution of Medical Device new product development, sustaining engineering activities, and quality issues that arise during post-production.

The individual will act as a quality expert and provide guidance to the business in interpreting and executing against company quality system elements to ensure compliance. This individual will ensure that all system-level project / program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet company’s quality, reliability, and compliance requirements. This candidate will have a strong Quality background and must be able to work in a team environment and be able to communicate clearly across all disciplines including Research & Development, Regulatory Affairs, Manufacturing, Marketing and Outside Partners and Regulatory Agencies.

POSITION RESPONSIBILITIES:

  • Lead risk management activities. Assure all applicable quality decisions are derived from the appropriate risk management document in accordance to the quality system.
  • Lead cross-functional teams with a focus on design controls in the preparation of Reliability/Risk Assessments, including post production issue triages for CAPAs, reliability predictions, Health Hazard Analyses, etc.;
  • Provide technical leadership for all quality deliverables defined by the Product Development process (PDP) and support the team to establish verification and validation strategies to assure an efficient approval path
  • Provide guidance and direction for sample size and statistical analysis of verification and validation test requirements and results.
  • Reviewing and providing feedback for changes to designs and processes, and assessing their impact to assure reliability requirements are met.
  • Stay abreast of applicable regulatory requirements. Actively seek out opportunities to understand current industry direction.

BASIC QUALIFICATIONS:

  • B.S. in Engineering or associated scientific discipline.
  • Minimum of 3 -5 years medical device experience in Quality or R&D Engineering position with design control and product development experience.
  • 2-4 years of experience with a Master’s Degree in a technical/engineering discipline; or
  • Medical or Pharmaceutical industry experience
  • Strong working knowledge of risk management and Design Controls.
  • Strong working knowledge of Medical Device Regulations, FDA Guidance Documents and Industry Standards.
  • Excellent problem solving skills, including demonstrated application of structured problem solving methods and tools
  • Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact
  • Proficient in Microsoft Word, Excel, Minitab and managing electronic data files


Posted: November 29, 2017, 10:14 am
Category : Quality Engineering
Job Type : Contract
Id : 7165
Region : Twin Cities

Seeking a Senior Risk Management – Design Quality Engineer to provide risk management quality engineering support in the design and development of innovative Medical Device products. The individual shall facilitate development of thorough, accurate and practical risk estimations, risk controls and risk/benefit analysis by working closely with Medical experts and other cross-functional teams to ensure product risks are compliant with standards based on ISO 14971.

POSITION RESPONSIBILITIES:

  • Plan, co-ordinate and execute Medical Device Risk Management activities to ensure the safety of Medical Device products throughout the lifecycle of the product from concept to end of life.
  • Lead risk assessments at the patient hazard level, the detailed design level, and from a human factors perspective.
  • Work with Systems Engineers to translate risk mitigations and safety needs into system/subsystem requirements and/or product design performance targets
  • Facilitate risk management activities to ensure DFMEA are completed at the system and subsystem level.
  • Facilitate risk management activities to ensure pFMEA are completed
  • Facilitate risk analysis tools such as DFMEA, HACCP, FTA, and HA with small development sub teams
  • Support the development of a state of art Risk Management process and system including both pre-market and post-market activities.
  • Serves as subject matter expert (SME) for risk management related to ISO 14971.
  • Coach and provide guidance to cross-functional teams regarding risk management processes.
  • Facilitate development of thorough, accurate and practical risk estimations, risk controls and risk/benefit analysis by working closely with Medical experts and other cross-functional teams.
  • Lead risk management activities. Assure all applicable quality decisions are derived from the appropriate risk management document in accordance to the quality system.
  • Responsible for risk management files including plan, analysis, and reports for product releases
  • Lead cross-functional teams with a focus on design controls in the preparation of Risk Assessments, including post production issue triages for CAPAs, reliability predictions, Health Hazard Analyses, etc

POSITION QUALIFICATIONS:

  • 4-6 years of experience with a Bachelor’s Degree in a technical/engineering discipline; or
  • 2-4 years of experience with a Master’s Degree in a technical/engineering discipline; or
  • Medical or Pharmaceutical industry experience
  • Experience authoring HA, FMEA, FTA, HACCP, and other similar risk analysis tools
  • Experience in risk management files and ISO 14971

PREFERRED QUALIFICATIONS:

  • Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
  • Experience in hemodialysis and renal care
  • Ability to manage multiple projects across multiple geographies
  • Excellent verbal and written skills
  • Able to work independently, as well as in a team environment
  • Customer focused and service oriented
  • Ability to educate stakeholders, customers and management
  • Ability to interface with internal customers, suppliers and regulatory agencies
  • Experienced working with cross-functional and international teams
  • Knowledge of FDA and TUV requirements
  • Travel up to 10%


Posted: November 29, 2017, 10:06 am
Category : Manufacturing Engineer
Job Type : Contract
Id : 7164
Region : Twin Cities

Seeking an experienced Manufacturing Engineer to collaborate with high volume facility engineering on Medical Device new product introduction (NPI) projects to concurrently develop assembly methods, tooling, equipment and processes.

 

POSITION RESPONSIBILITIES:

  • Partner with development and utilize DRM /COS/ lean principles to develop solutions to complex problems through the use of ingenuity and creativity ensuring practical technical solutions for product assembly which are and consistent with organization objectives.
  • Collaborate with high volume facilities to ensure the solutions for product assembly meet organization objectives for metrics such as product cost, labor time, yield, lead time.
  • Daily interaction with pilot development teams providing hands-on support for development build
  • Utilize DRM principles to thoroughly evaluate requirements for new products in terms of the test method, process capability and relationship to the customer needs.
  • Create standardized work charts, work combination tables and process maps that result in an optimized production system and extended value stream.

 

POSITION REQUIREMENTS:

  • Medical device process validation experience
  • Travel to Puerto Rico (1-2 weeks/month) as needed
  • Implantable leads/extensions process development experience
  • Hands on experience with process development
  • Test Method validation for Manufacturing inspection methods
  • Process Characterization experience in the following processes
  • Injection molding
  • Laser welding
  • Centerless grinding

 

 



Posted: November 29, 2017, 8:30 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 : 7160
Region : Twin Cities

Seeking a Design Technician to work with an Implantable Medical Device, Systems Integration and Test function group whose charter is to provide engineering development and support of characterization, integration, verification and validation strategies for new product development. This position is entry level, working with an interdisciplinary team of systems engineers and technicians to execute test plans/protocols and other laboratory work in support of system level testing of Implantable medical device products.

Position Responsibilities:

  • Execute characterization test and support analysis of data to understand capability.
  • 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.
  • Maintain lab, including equipment calibration and qualification.
  • Maintain inventory tracking of test supplies, samples and equipment.
  • Identify and order / re-order lab consumables and supplies.
  • Under the supervision of senior technician installs new equipment.
  • Work collaboratively with engineers to evaluate and improve design.
  • Report status and results of work on a regular basis.
  • Communicate clearly and effectively in a timely manner.
  • Develop understanding of and perform testing involving electrical, hardware, firmware, software, and/or telemetry interfaces.
  • Under the supervision of senior technician design and redesign devices, machines, fixtures, assembly methods, test systems, and components.
  • Identify opportunities for system level test automation.
  • Perform job functions under close supervision.

Basic Qualifications:

  • Associates Degree


Preferred Qualifications:

  • 2 year Associate Science Degree.
  • 2 years’ experience in medical device laboratory and test setting.
  • Workable knowledge of scientific and/or laboratory techniques.
  • Good verbal and written English skills.
  • Ability to work under supervision and follow general direction for work.
  • Ability to build and test mechanical models, electrical circuits and assemblies.
  • Familiar with lab equipment like Oscilloscope, Fluke meter etc.
  • Experience with Microsoft Office.


Posted: November 17, 2017, 12:07 pm
Category : Software Engineer
Job Type : Contract
Id : 7158
Region : Twin Cities

Seeking a Software Engineer to work with Application Development and Released Product Engineering teams to develop and maintain the next generation medical technologies that save lives, improve quality of living for millions of patients across the world. These cutting-edge teams 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. These teams are 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)
  • Strong programming skills in C#, .NET AND/OR C/C++
  • Strong knowledge of software design, development, debug and test practices
  • Strong oral and written communication skills
  • Experience with configuration management tools
  • Proficiency working in a team environment

PREFERRED QUALIFICATIONS:

  • 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
  • Experience with applications that support Medical Devices and highly regulated products


Posted: November 16, 2017, 6:23 am
Category : Quality Engineer - Medical Device
Job Type : Contract
Id : 7157
Region : Twin Cities

The Design Assurance Engineer provides technical engineering support to new product development and sustaining engineering teams in the medical device industry. This individual will be expected to apply his/her knowledge of design control principles and quality engineering techniques to these development and sustaining 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.

Position Responsibilities:

  • Executes quality engineering deliverables required by the Product Development Process.
  • Identifies and manages risk throughout the development process and sustaining efforts with the use of FMECA and/or other risk management tools.
  • Participates in developing master test plans that encompass design verification, design validation and process validation activities.
  • Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
  • Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
  • Participates in supplier selection process and specification reviews with suppliers to ensure that purchased items meet company specifications.
  • Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices.
  • Supports sustaining engineering efforts on commercialized products

Required Qualifications:

  • BS in engineering or science. MS desirable.
  • 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
  • 1 - 3 years of experience in Quality Assurance, including Quality systems, standards, metrics, and tools desirable


Posted: November 15, 2017, 8:25 am
Category : Mechanical Designer
Job Type : Contract
Id : 7156
Region : Twin Cities

The Mechanical Design Engineer will support the design and post-market support of implantable medical devices. 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 role also develops technical solutions to problems that require ingenuity and creativity. Applies technical expertise and has knowledge of other related disciplines such as manufacturing and process technologies. Represents the design organization as the primary design contact for continuous improvement, CAPA, and returned product analysis initiatives.

BASIC REQUIREMENTS:

  • B.S. in engineering or appropriate technical discipline
  • Knowledge of manufacturing, clinical, and regulatory requirements
  • 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 REQUIREMENTS:

  • Minimum of 3 years in either a manufacturing or post-market product development support role, preferably 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: November 15, 2017, 8:19 am
Category : Technician - R&D
Job Type : Contract
Id : 7151
Region : Twin Cities

We're looking for a Dialysis R&D Test Technician to provide Engineering test and equipment support for development of hemodialysis-related systems.

Job Description:

  • Assemble, test, debug and trouble shoot electro-mechanical test equipment. Interface instruments and actuators to prototypes and test systems
  • Independently set up test equipment and efficiently execute manual and automated tests.
  • 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.
  • Accurately and thoroughly document test results to meet quality system requirements.
  • Follow applicable quality system procedures governing development of a medical device.

Job Qualifications:

  • Associate degree in a technical field such as electronics, mechanical technology, or software programming.
  • Minimum 2 years' experience in engineering test supporting new product development
  • Ability to fabricate circuits, and interface instruments and acutators to sofware controls.
  • Familiarity with embedded systems and software. Familiarity with LabVIEW.
  • 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.
  • 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: November 13, 2017, 9:25 am
Category : Hardware Engineer
Job Type : Contract
Id : 7147
Region : Twin Cities

Seeking an Embedded Hardware Engineer to design and develop verification environments, test benches, tools, and methodologies used to evaluate a medical device based on an embedded architecture. This job requires the development and operation of tools in a UNIX/LINUX operating system. This job requires knowledge of embedded device verification, which requires formal documentation, technical reviews, and demonstrating compliance to regulations. This job requires knowledge of an embedded device consisting of a microprocessor and embedded firmware.

POSITION RESPONSIBILITIES:

  • Develop verification environments, tools, capabilities and methodologies that increase the productivity and effectiveness of the design teams. Familiar with application of verification methodologies like directed test, assertions, constrained random, UVM/OVM. Familiar with the use of scripting like Perl, Python, Makefiles used to package tool flows. Use of a high level object oriented software language such as SystemC, C, C++, SystemVerilog in the development of verification environments.
  • Work with device architects, chips architects, digital designers, analog designers, and firmware designers to integrate a device model in simulation (i.e. SystemC, RTL, Verilog, C) or hardware (i.e. breadboard, FPGAs) into an evaluation environment.
  • Use debug tools to identify issues and support root cause analysis.
  • Team with engineering development teams to achieve program goals; willingness to adapt and take on a variety of tasks as projects evolve. Contributes to the open exchange of information and ideas; actively listens to others.

BASIC QUALIFICATIONS:

  • B.S. in Electrical Engineering or related field
  • 7 years related experience
  • Experience in RTL design and verification
  • High-level programming experience such as C++
  • Familiar with circuit design and circuit simulation tools

PREFERRED QUALIFICATIONS:

  • Familiar with Hardware Assisted Verification using HW emulation, RTL acceleration


Posted: November 9, 2017, 12:13 pm
Category : Manufacturing Engineer
Job Type : Contract
Id : 7138
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 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 (TUV/FDA). Prior experience with ceramics, furnace applications, vacuum systems or physical deposition would be beneficial but not required.  Must have a Bachelor's Degree and 3-5 years Medical Device experince. 

.



Posted: November 3, 2017, 8:30 am
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 : Quality/Regulatory
Job Type : Contract
Id : 7130
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, English, Technical writing/Editing, Graphic design or computer science
  • 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
  • Experience working with Adobe Illustrator and/or other graphic design programs
  • 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: October 27, 2017, 7:00 am
Category : Software Engineer
Job Type : Permanent
Id : 7129
Region : Twin Cities

We are looking for a software developer to join our engineering team. This individual would be working on a wide variety of software projects for 2D and 3D sensors. This includes software for:

  • Communication with a wide variety of hardware such as cameras, motion control systems and a variety of sensors
  • Implementing image processing and other algorithmic procedures
  • Manufacturing and testing of production and development sensors
  • Software Development Kits and User interfaces for PC host applications

Core Responsibilities:

  • Design and implement software for a variety of sensors projects such as host control APIs and applications, manufacturing applications and test harnesses.
  • Documentation of software designs and communications interfaces
  • Working with multi-discipline engineering teams throughout all phases of development
  • Supporting and troubleshooting sensor and software field issues
  • Helping to define software architectures that will help us promote agile development

Experience, Education and Competencies Required:

  • BS Degree in Computer Science, Math or a related engineering field
  • 5+ years’ experience in software development in an engineering environment
  • Proficiency in C, C++ and C# development using Visual Studio
  • Ability to work independently on projects as well as interact with multi-discipline engineering teams in a fast paced agile environment.
  • Strong technical communication abilities

Experience, Education and Competencies Preferred:

  • Strong background in math and proficiency in basic image processing and 3D math functions
  • Experience with Matlab and Python
  • Ability to work with diverse SDKs, interfaces and libraries from external vendors
  • Experience writing software to communicate with external hardware such cameras, machine control systems and other types of sensors using TCP-IP, RS323, USB, PCIe and other standard protocols.
  • Experience with agile software development and working in a scrum team
  • Experience in developing software architectures that promote agile development


Posted: October 26, 2017, 6:56 am
Category : Quality/Regulatory
Job Type : Permanent
Id : 7127
Region : Twin Cities

Seeking a Compliance Engineer to drive and execute the company’s testing compliance programs through innovative problem solving and product, project management. This position will functions as technical consultant to internal functions and independent testing vendors.

POSITION DESCRIPTION:

  • Manage and oversee projects for product certification to various industry standards.
  • Work in tandem with internal Engineering, Product Management, Manufacturing team members and outside labs, supply-chain partners, registrars, etc., to determine precise scope(s) and objectives of test programs.
  • Define individual test plan(s) and time schedule in alignment with engineering development and project management schedules.
  • Communicate tasks and requirements to internal and external parties.
  • Regularly document progress and results and communicate progress to management.
  • Review, synthesize and coordinate external and internal task requirements and assignments on an ongoing basis.
  • Determine project plans, checklists and timelines based on project requirements and determine resource availability.
  • Identify and communicate process and design improvement opportunities and/or investments in equipment or services that are needed to produce positive test results.
  • Review test data and test results relative to compliance requirements and maintain compliance data base.
  • Foster a sense of urgency and spirit of cooperation that fulfills Clearfield company values.
  • Utilize knowledge of mechanical engineering, independent test labs, and applicable industry standards to act as technical consultant to the Design and Application Engineering, Manufacturing Operations and Product Management teams.
  • Identify gaps and non-compliance issues and work closely with cross-functional teams to close those gaps.
  • Troubleshoot failures and recommend and/or support corrective action.
  • Assist in the development of manufacturing processes and necessary documentation for new products.
  • Define and develop testing procedures and methods for qualification of new product developed both internally and with external partners.
  • Assist Mfg. Engineering in the design and development of internal and external procedures for manufacturing, assembly, testing, and packaging, as per industry accepted standards.
  • Review internal and external party technical documentation to assure all compliance requirements are met.
  • Specify equipment as necessary for testing throughout the manufacturing and qualification processes.
  • Identify problems or risks, in relation to the test programs, collect and analyze data and develop test solutions support from the concept stage of a new product through production manufacturing.
  • Suggest alternatives in design or process needed to produce positive qualification results to internal and external parties, during design reviews, and elsewhere as applicable.
  • Work proactively with other members of the engineering and product management staff where possible, providing input and assistance on design, manufacturing, quality, process and test issues.
  • Remain abreast of current industry, supplier, and technology advancements and standards to ensure company's products remain marketable and competitive.

POSITION REQUIREMENTS:

  • Bachelor’s degree, Mechanical Engineering
  • Thorough knowledge or experience with telecommunications testing standards and specifications such as Telcordia and UL.
  • Background in fiber termination and passive optical products used throughout the telecom and communications industry
  • Four years’ experience in product testing/certifications
  • Excellent organizational, decision making, and communication skills
  • Strong problem-solving skills
  • EIT Certificate helpful


Posted: October 25, 2017, 8:37 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 : Software Engineer
Job Type : Contract
Id : 7125
Region : Twin Cities

Seeking a Software Engineer to be responsible for defining, implementing, executing, and documenting software for the next generation of company 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.

 

DESIRED/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: October 23, 2017, 8:31 am
Category : Software Engineer
Job Type : Contract
Id : 7124
Region : Twin Cities

Seeking a 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.

 

This role requires the ability to understand moderately complex technologies, coupled with the technical skills to transpose both into a systematic test framework. This is a highly trusted position that requires an individual to think independently, be decisive, and need minimum supervision.

 

POSITION RESPONSIBILITIES:

  • Create and document all aspects of the software engineering processes for products under development, incorporating the highest quality standards, cost effectiveness, and measurable efficiency.
  • Coordinate software development activities with other engineers, and managers.
  • Support the test automation strategy and implementation.
  • Meet all project milestones and deliverables, as required by the project leadership.
  • Manage the design and implementation process and evidence gathering.
  • 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.

 

EDUCATION REQUIRED:

  • Bachelors of Science or greater.
  • Bachelor's Degree: 4+ years or Master's Degree: 2+ years

 

DESIRED/PREFERRED QUALIFICATIONS:

  • BS and/or MS in Computer Science, Software Engineering or Computer Engineering.
  • 1+ year 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.
  • Knowledge of software test architecture and software tools for mobile software applications.
  • Experience with layered architecture, MVC, Design Patterns.
  • Experience with configuration management tools and best practices (GIT, github, 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.
  • Good understanding of REST based web services.
  • Proficiency with selecting and training candidates for the execution of test tasks.
  • Understanding of multi-tenant/multi-user paradigm.
  • Experience with Microsoft Technologies (MS Project, MS Project Server, SharePoint, Office).


Posted: October 23, 2017, 8:19 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. Prefer 0-3+ 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