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Sr. Product Development Engineer
3 months ago
Our smaller bioelectronic medical device client is adding a Sr. Product Development Engineer to the team. This is a customer facing role with project management responsibilities and leading project meetings with customers and internal team members. Responsible for development and implementation of new products, developed jointly with Manufacturing Engineering, into full production, as well as supporting of continuation engineering on existing product lines.
Your role with the company:
Product Concept
- Understands user and patient needs
- Proposes concepts to address customer needs
- Selects and documents concepts to proceed to development and commercialization
- Generates intellectual property
- Participates in strategic planning
Design & Development - Translates customer requirements into engineering specifications.
- Plans and manages creation of models to simulate and analyze device function.
- Plans and manages development of test fixtures and methods.
- Analyzes and optimizes design concepts through experimentation and other simulation.
- Conducts risk assessment (e.g. DFMEA) of product concepts.
- Conducts feasibility studies and documents results and recommendations in technical reports.
- Participates in project planning, costing, and business case
Verification & Validation - Completes engineering documentation (e.g. Product & component specifications, BOMs, etc.) in readiness for design verification and validation.
- Writes design verification and validation protocols and reports
- Coordinates verification and validation builds.
- Collaborates with other functions to execute project deliverables
- Develops standard documentation methodologies
Work Conditions
- Use manual and light power tools to make and test prototypes
- Works in a development lab environment in addition to office.
- May be in and around a tool shop
- May be in a cleanroom or controlled environment area - Working Through Others/Interpersonal Relationships
- Establishes extensive interdepartmental and interdivisional networks
- Has an in-depth understanding of the various organizational interfaces (laboratory, engineering, sales and marketing)
- Implements comprehensive educational plans to develop, maintain, and expand state-of-the-art knowledge in
Education:
•Bachelor's degree in Mechanical, Electrial, Chemical, bio-medical engineering or equivalent.
Experience:
- 4+ years engineer experience in medical device industry.
- Good working knowledge of design controls and quality system regulations.
- Experience working in a fast-paced environment that is collaborative, the ideal candidate will be able to work on 2-3 projects and be able to pivot from one to the other based on priority.
- To be successful, candidate will have traits that align with evaluating and creating designs and being able to help lead our customers down the best path for their product. This involves evaluating functionality, cost, and timelines while working with the customer and internal teams.
