**New Permanent Role – R&D Senior Staff Engineer**
Location – Franklin Lakes NJ – United States
Salary $200k - $260k & Benefits Package
Industry – Medical Device
The R&D Senior Staff Engineer will impact health care and the CCMD (Catheter Care and Medication Delivery) business groups by driving the commercialization of new products and design changes for current products through development, qualification and launch phases.
The R&D Senior Staff Engineer contributes to building organizational effectiveness through creating, leveraging and sharing best practices; leading and mentoring others; seeking and providing training; driving technical and workflow innovation.
While maintaining a Customer Focus, responsibilities include (but are not limited to): Strategy development and Execution for Qualification of Medical Devices inclusive of Design Verification, Design Validation and Design Transfer activities.
- Creating, editing, and interpreting technical drawings
- Design Verification Strategy Development
- Functional Device Testing
- Testing by Analysis
- Design Validation Strategy Development
- End User Validation Testing
- Technical writing (protocols, reports, work instructions, presentations, etc.) and effective verbal communication
- Expert application of engineering principles for design / analysis
- Statistical analysis and sample plan development
- Identifies external technologies
- Identifies critical strengths and weaknesses
- Nurtures IDR's (Invention Disclosure Records) from infancy
- Continuous Learning
- Participates in external activities to enhance the brand recognition of BD by writing papers and generating IP (Intellectual Property)
The R&D Associate Senior Staff Engineer will demonstrate and cultivate:
Accountability: strong and clear accountability for the successful and timely achievement of goals.
Ability to assess project / program needs, engage and mentor team members, formulate strategy, build support, and execute; proactively identify and mitigate risks.
Maintains responsibility for BDG's (Business Development Goals)
Proposes strategies to build functional capability
Represents BD's interests to external policy making stakeholders (E.G. Standards committees)
- Hold and encourage frequent formal and informal communication within the team and the rest of the organization to ensure dissemination of important information.
- Demonstrated ability to communicate up to VP level
- Final recommendations to decision making committees
- Resolves conflicts within team by facilitating communication
- Strong interpersonal influence and persuasion skills; situational awareness; ability to persuade or be persuaded based on evidence with or without authority.
Inclusive work environment.
- Promote and leverage diversity to achieve best outcomes.
Decisiveness Despite Ambiguity:
- Developing agility and action orientated when facing change and uncertainty.
- Autonomy and Empowerment: ability to lead and mentor others.
- Autonomously drives projects/deliverables.
- Bachelor’s Degree in Mechanical or Biomedical Engineering and 8+ years of experience in medical device or other regulated industry OR Advanced Degree in Mechanical or Biomedical Engineering.
- Track record of technical problem solving and effective product development.
- Design controls expertise for Medical or regulated industry experience.
- Proficient in statistical methods / tools
- Proficient in solid mechanics / mechanics of materials
- Familiarity with traditional and modern fabrication techniques
- Knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO14971 and ISO 80369 and collateral standards.
Preferred Qualifications and Knowledge:
- Graduate degree (MS or Phd) in Mechanical Engineering, Biomedical Engineering or similar
- 10+ years of post-educational experience in Medical Device
- Sought as an SME (Subject Matter Expert) in one or more areas expertise
Additional Desired Qualifications and Knowledge:
- Experience with Electro Mechanical product development and testing related to IEC 60601.
- Experience with System Engineering methodologies (INCOSE, Product Requirements transformation from User Needs)