R&D Engineer
Job Description:
The Engineer will contribute to the planning, design, building, and qualification of measurement systems and methods vital to the evaluation of product safety, efficacy, performance, and compliance while ensuring accurate completion of project and business goals. You will contribute to the strategy and drive the execution of product design verification and validation activities to demonstrate product safety, efficacy, performance, and compliance.
Knowledge, Skills & Abilities:
- Team leadership and coordination experience.
- “Can do attitude” and history of rapidly driving projects, milestones and activities.
- Ability to critically dissect problems, ideate creative options, and communication that drives objective team decisions.
- Ability to plan before execution Onsite work for best practice lab utilization.
Duties & Responsibilities
- Contribute to planning through all project phases with a focus on strategy, planning and execution of design verification.
- Ownership of design verification including but not limited to plans, protocols, execution, rationales, data analysis and reports.
- Technical writing and oral technical communication across product development disciplines.
- Craft, edit, and interpret technical drawings and write protocols, reports, work instructions, presentations, etc.
- Apply engineering principles for design/analysis and complete statistical analysis and sample plan development.
- Demonstrate accountability for the successful and timely achievement of goals.
- Drive innovation and process efficiency.
Education & Experience
- Minimum 5 years of experience in medical device or other regulated industry.
- Experience with test method development, validation strategy, and execution is required.
- Experience with design verification & validation strategy development and execution is required.
- Track record of technical problem solving and effective product development through application of engineering principles is required.
- Design controls experience and exposure to traditional and modern fabrication techniques is required.
- Proficiency in solid mechanics/mechanics of materials and experience to statistical methods / tools is required.
- Experience in solid modeling (SolidWorks)
- DFSS training or certifications are a plus.
Provide answers to the below Screening Questions:
- How familiar are you with design control, MDD, MDR, Standards Compliance?
- What is your experience in creating / managing / auditing design history files for medical devices?
- What is your experience with creating Design Verification plans/protocols/reports? Have you ever performed root cause analyses?
- Do you have experience using statistical software (i.e. Minitab)? Have you performed t-tests, ANOVAs, capability analyses, etc.?
- What has been your most challenging problem in your career so far from a Verification and Validation perspective (close second works too)? What steps did you take to solve it? Who did you involve? What was the outcome?
- Top 3 responsibilities in current position and % of time spent on each?
- What is your experience with CAD software (i.e. ProE, SolidWorks)?