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

MillenniumSoft Inc; Franklin Lakes (NJ); On-site; USD 62,000 - 69,000; Full time

Job summary

MillenniumSoft Inc. is seeking a Sr. Mechanical Engineer for the R&D Test Method Development, Verification & Validation team within Medical Device Medication Delivery Solutions.

The incumbent will lead test method development, verification activities and measurement-system design for drug-delivery products. The ideal candidate will plan and execute cross-functional project work, apply engineering first principles, and contribute to design verification/validation.

Qualifications

• R&D Test Method Development, Verification & Validation experience in medical devices.
• Contract Engineer with ability to lead V&V activities.
• Experience designing verification strategies and measurement systems.
• Strong problem solving and root cause analysis skills.
• Ability to collaborate with cross-functional engineering teams.

Responsibilities

• Provide technical direction and oversight of V&V test method development activities.
• Plan and execute technical project work applying engineering principles.
• Collaborate with Systems and Engineering teams to derive product specifications.
• Create and document novel test methodologies for product changes.
• Resolve technical problems using systematic approaches and statistics.
• Develop Design Verification strategy and provide stakeholder feedback.
• Mentor associates and promote technical skill development.
• Ensure compliance with quality policies and safety regulations.

Skills

Test Method Development

Verification & Validation

Measurement Systems

Fixture Design

Statistical Analysis

Cross-Functional Collaboration

Design Verification

Problem Solving

Mentoring

Tools

Fixture Design

Measurement Equipment

Statistics Software

Job description

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

Location: Franklin Lakes, NJ

Duration: 12+ Months Contract

Total Hours/week: 40.00

pay rate-$45-50/hr

1st Shift

Client: Medical Device Company

Job Category: Engineering

Level Of Experience: Seniority Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

Description

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.

Responsibilities

• 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 the planning and execution of technical project work. This will involve the application of engineering first principles and advanced engineering methods to gain deep understanding of the underlying technical issues, and 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.
• Expected to mentor associates in related technical roles. Provide technical direction and frequent feedback.
• Developing personal skills, expertise, and competencies. Ensure that 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