***New Permanent Role – Staff - Design Verification Engineer***
Location – New Jersey
Salary – $150k & Benefits Package
Industry – Medical Device
The R&D Staff Engineer will impact health care and the MDS business groups by driving commercialization of new products and design changes for current products through development, qualification and launch phases.
The R&D Staff Engineer contributes to building organizational effectiveness through creating, leveraging, and sharing best practices; seeking and providing training; driving technical and workflow innovation.
Project Responsibilities
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.
This requires:
- Creating, editing, and interpreting technical drawings
- PRIMARY: Design Verification Strategy Development
- Functional Device Testing
- Testing by Analysis
- 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
- SECONDARY: Design Validation Strategy Development
- End User Validation Testing
Innovation
- 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 by writing papers and generating IP (Intellectual Property)
Leadership
The R&D 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.
Proposes strategies to build functional capability.
Effective Communication:
- Hold and encourage frequent formal and informal communication within the team and the rest of the organization to ensure dissemination of important information.
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- Final recommendations to decision making committees.
- Resolves conflicts within a team by facilitating communication.
Organizational Influence:
- 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.
- Autonomously drives projects/deliverables.
Required Qualifications
- Bachelor’s Degree in Mechanical or Biomedical Engineering with a min of 6+ years of experience in medical devices 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
- Solid Understanding of Design Verification for Mechanical Components
- 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
- 8+ years of post-educational experience in Medical Device
- Sought as an SME (Subject Matter Expert) in one or more areas expertise.
