Staff - Design Verification Engineer

Job Type:
Perm
Sector:
IT leadership
Location:
USA
Salary:
$150k & Benefits Package
Ref #:
5836589

***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.
  •  
  • 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.

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