R&D Product Development Engineer (Must Have INSTRON)

MillenniumSoft Inc; Franklin Lakes (NJ); On-site; USD 28,000 - 41,000; Full time

Job summary

Medical Device Company in Franklin Lakes, NJ, seeks an R&D Product Development Engineer with must-have INSTRON experience for a 12+ month contract. You will lead test method development, fixture design, and measurement system validation for pharmacologic delivery or similar devices.

Experience with design controls and MSA is valued. The role requires hands-on Instron operation, CAD samples, and collaboration across design, development, and V&V teams to ensure testable requirements and robust

Qualifications

• Experience in test method development and fixture design.
• Hands-on experience with Instron and related software for method development.
• Ability to lead Verification & Validation activities in cross-functional teams.
• Knowledge of Design for Six Sigma (DFSS) and measurement systems analysis (MSA).
• Willingness to attach CAD samples and demonstrate relevant work.

Responsibilities

• Define, plan and lead test method development and fixture design for DV/Verifications.
• Collaborate with Design, Systems, and V&V teams to ensure testability of requirements.
• Apply systematic problem solving to resolve technical issues using DFSS/DSA tools.
• Create and document new test methodologies and provide feedback for product changes.
• Ensure compliance with BD quality policies and safety regulations.

Skills

Instron testing

Engineering leadership

Project management

Test method development

DFSS / Six Sigma

CAD design

MSA knowledge

Communication

Tools

SolidWorks

Pro/E

Microsoft Project

Job description

Title: R&D Product Development Engineer (Must Have INSTRON)

Location: Franklin Lakes, NJ

Duration: 12+ Months

pay rate-$20-30/hr

Shift/Hours: 1st Shift ( 8-9am to 4-5pm) / 40hrs

Client: Medical Device Company

Job Category: Research & Development Engineering

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

No H1B’s

Description

Prescreening questions please attach answers with resume:1. Top 3 responsibilities in current position and % of time spent on each

• What are you looking for in your next position?
• How passionate are you about designing test fixtures for test method development versus designing parts/products for new product development?
• Do you have hands‑on experience developing test methods? Specifically, have you designed test fixtures, written Test Instructions, performed MSAs (Gage R&Rs) to qualify test methods? If so, give at least one example and explain in detail.
• What has been your most challenging problem in your career so far (close second works too)? What steps did you take to solve it? Who did you involve? What was the outcome?
• How familiar are you with design control?

Candidates submitted must have INSTRON experience and be able to operate Instron. Must understand how the software is installed to develop methods. Blue hill , Tensile etc.

ATTACH Samples of CAD work.

The Client Medical - Medication Delivery Solutions (MDS) V&V team 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 the Verification & Validation Test Engineering team, providing technical leadership and support to a cross‑functional team. The successful candidate will be responsible for supporting product verification activities and will lead test method development activities, measurement system development & analyses, test fixture design and equipment hardware/software validation of measurement system equipment. He/she will ensure that translated product requirements are testable and measurable. The ideal candidate will also 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. Up to 2 years of test method development experience preferred.

Responsibilities

Specific responsibilities will include the following as well as other duties as assigned:

• 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 Design & Development, Systems Engineering and V&V Engineering teams to ensure that product requirements are testable and measurable.
• 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.
• Use DFSS tools throughout the measurement system development process to improve method selection decisions and reduce method development iteration cycle times.
• Conduct and encourage frequent formal and informal communication with the team to ensure full engagement and efficient operation.
• Actively build on 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 BD safety regulations, policies, and procedures.

Skills

• Strong technical judgment and extensive technical leadership skills.
• Sound knowledge of engineering first principles.
• Strong project management, prioritizing and multi‑tasking skills to work within tight deadlines. Proficient in Microsoft Project.
• Proficient in solid modeling (Pro/E, SolidWorks or equivalent).
• Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
• Experience in directing associates and leading small cross‑functional groups is required.
• Proficiency with fixture design including basic machining considerations and developing test methods.
• Strong knowledge of Measurement Systems Analysis (MSA).
• Knowledge of Six Sigma (DMAIC) practices, and Design for Six Sigma (DFSS) methodologies.
• Strong creative, analytical and problem solving skills required.
• Good written & verbal communication skills.