Sr. Mechanical Engineer; Test Method Development, Verification, Medical Device

Position

Sr. Mechanical Engineer (Must Have Test Method Development, Verification, Medical Device)

Franklin Lakes, NJ

12+ Months Contract

40.00 hours/week

1st Shift

Medical Device Company

Engineering

Senior

Contract on W2 (US Citizens or GC Holders Only)

The R&D Test Method Development, Verification & Validation (TMD / VnV) team within Client Medical - Medication Delivery Solutions (MDS) is seeking a highly talented and passionate individual to help the team identify innovative solutions to address current and future health care needs in the medication delivery markets.

The incumbent will join as a Contract Engineer, requiring moderate oversight and providing technical leadership and support to a cross‑functional team. The successful candidate will be responsible for supporting product verification activities; contributing to — and possibly leading — test method development activities; measurement system development, analysis and qualification; test fixture design; creation and execution of design verification strategies required for sustaining existing and commercialization of various types of new medical device products used in drug delivery.

The ideal candidate will plan and participate in executing technical and cross‑functional project work which may include all phases of product development, including: design and development planning; requirements definition; product development; root cause analysis; test method development; and design verification/validation. Additionally, the candidate will be expected to participate in the development of new technologies for testing products that will help meet current and future clinical unmet needs.

• Provide technical direction and oversight of V&V test method development activities. Define, plan and lead activities, including test method & measurement system development and validation, fixture design and testing optimization in support of Design Verification.
• Participate in planning and execution of technical project work, applying engineering first principles and advanced engineering methods to propose and implement robust solutions.
• Collaborate with Systems and Engineering teams to understand and derive specifications for a broad portfolio of MDS products.
• Create and document novel test methodologies and provide feedback and recommendations for product/design changes.
• Resolve technical problems. Identify or create solutions for technical problems using systematic problem‑solving and statistical methodologies.
• Support project plan development and contribute to the development of the Design Verification strategy.
• Conduct and encourage frequent formal and informal communication with the team to ensure full engagement and efficient operation.
• Mentor associates in related technical roles, providing technical direction and frequent feedback.
• Develop personal skills, expertise, and competencies; ensure technical lessons are reviewed, learned, and disseminated.
• Ensure compliance with BD quality policies, procedures, and practices.
• Ensure compliance with all local, state, federal, and Client safety regulations, policies, and procedures.