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Senior R&D Engineer - #995

Employer
Medical Engineering Consultants
Location
Minneapolis
Salary
Competitive

View more

Industry
Healthcare
Role
Engineer
Job Type
Long-Term
Hours
Full Time

Summary:

Seeking cardiac implantable (leads/catheter) design expertise with a Technical Leader skillset. This individual will serve as a team member assigned to short term engagements on projects as needed. Initial assignment requires knowledge of cardiac implantables (leads/catheters), their design, and steroid drug interaction/usefulness.

Top 6 needed skills:

  • Lead/Catheter design
  • Pharma, especially as related to steroid use on implants
  • Bench test and test method experience
  • Risk burn down methodology
  • Agile experience
  • Design control experience


Orchestrate the identification of technical strategies, solving of technical problems and completion of deliverables, among team members both internal and external to the design group. React to challenges, set-backs, scope-changes, etc., formulating an action plan, and leading the design team to forge a new path forward. Lead, direct, and/or review the work of technical team to execute the technical plan.


Responsibilities:

  • Design, develop, analyze, troubleshoot, and provide technical skills during research and/or product development
  • Translate customer needs to device or therapy concepts
  • Create prototype concepts and lead down selection process for final concept
  • Institute design changes based on internal and external customer feedback
  • Perform job functions in accordance with applicable GMP and ISO standards
  • Comply with applicable FDA and international regulatory laws and standards


Deliverables/ Documentation:

  • While working with other team members, complete the deliverables such as VOx Assessment, Solution Definition, Risk Register, Design Input Requirements, Design Specification, Print generation, Design Characterization/DRM tasks, Solution Definition TAC, Design Validation, Process Planning Matrix, regulatory submission-ready documents for the FDA and other regulatory bodies, and others as necessary. While ultimately accountable for these tasks, may delegate responsibility as appropriate for individual deliverables.
  • Write protocols, reports, and presentation of analytical and interpretative nature to communicate results


Testing & Analysis:

  • Designs studies to investigate specific performance and therapy attributes
  • Responsible for technical execution of experiments utilizing DRM methodologies; define and develop tests and test methods to meet product requirements
  • Define QMS approach such as to leverage designs/documentation
  • Assess the performance of developed devices through execution of structured experimental plans to drive data-based decisions
  • Perform risk / failure mode assessment, plan and conduct performance and safety testing and ensure mitigations are in place for designs
  • Partake in verification and validation of designs and processes


Industry Knowledge:


  • Understand anatomy, disease states, clinical use cases and user interface requirements and using these to drive the definition of product requirements
  • Interact and build relationships with physicians as well as sales and marketing partners



*Sponsorship/ Corp to Corp is not available for this position.

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