Product Development Engineer

---

Job description

Each Resume submitted must have the following pre-qualifying questions answered with the resume:
1. How familiar are you with design control, MDD, MDR, Standards Compliance?

2. What is your experience in creating / managing / auditing design history files for medical devices?

3. What is your experience with creating Design Verification plans/protocols/reports? Have you ever performed root cause analyses?

4. Do you have experience using statistical software (i.e. Minitab)? Have you performed t-tests, ANOVAs, capability analyses, etc.?

5. 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?

6. Top 3 responsibilities in current position and % of time spent on each?

7. What is your experience with CAD software (i.e. ProE, SolidWorks)?

Must have design control and at least 3+ years of Med Device. Strong Communication and written skills. Statistical background.

Requirements:
- BS in Mechanical Eng. or Biomedical Eng is required
- MS in closely related field is preferred
- 3+ years of experience in Medical Device Industry working in Product Development/ R&D
- Must have participated or led Product Development projects and established a successful track record
- Ability to gather user needs, translate them to technical inputs
- Develop viable V&V (Design Verification and Validation) plans
- Working knowledge of Medical Device Risk Management
- Proven ability to assess root cause of issues and propose solutions
- Able to foresee project risk and develop mitigation plans
- Self-Starter, Agile, Flexible, Quick Learner
- Good Communicator, Good Listener
- Strong Work Ethic and practices BD's Values

Research and Development Engineering is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices. Demonstrates working knowledge of Engineering principles and its application in solving standard technical problems. Demonstrates working knowledge of product design and development. Demonstrates working knowledge of design control process. Tests, analyzes and solves technical problems with moderate guidance. Applies basic statistical techniques and utilizes design of experiments with moderate guidance. Translates customer needs into design inputs; verifies design output meets design input. Works with moderate guidance. Translates requirements into basic designs under the guidance of others. Creates and tests prototypes. Maps the intellectual property landscape. Has developed knowledge and skills in own job family; still acquiring / expanding fundamental knowledge and higher-level skills. Applies knowledge and skills to a variety of standard activities. Works with moderate guidance in own area of knowledge.