Sr. R&D Engineer (Product Development Activities)

MillenniumSoft Inc; Franklin Lakes (NJ); On-site; USD 114,616,000 - 157,597,000; Full time

Job summary

MillenniumSoft Inc is seeking a Sr. R&D Engineer for product development activities in Franklin Lakes, NJ. The role focuses on writing and executing Design Verification plans, protocols, and reports, with strong data analysis and cross-functional collaboration to meet milestones.

The candidate should have 6+ years in medical device design/development, a mechanical or biomedical engineering background, and prefer a Master’s degree. FDA device experience is a plus for this contract role.

Qualifications

• 6+ years of product design/development experience in medical device or regulated industry.
• Bachelor’s degree in Mechanical or Biomedical Engineering (Mechanics focus).
• Master’s degree or above preferred.
• Experience with FDA Class II or III medical devices preferred.

Responsibilities

• Write and execute Design Verification testing with protocols and data collection.
• Develop and defend engineering rationales for product development activities.
• Communicate technical concepts clearly to cross-functional teams.

Skills

Design Verification

Data analysis

Cross-functional team

Written communication

Decision making

Education

Bachelor’s in Mechanical Engineering

Master’s degree preferred

Job description

Position: Sr. R&D Engineer (Product Development Activities)

Location: Franklin Lakes, NJ

Duration: 12+ Months contract

Total Hours/week: 40.00

pay rate-$40-55/hr

1st Shift

Client: Medical Device Company

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

No H1b’s

Description

• Demonstrated experience writing complex Design Verification plans, protocols, reports
• Proficiency with statistical techniques including Minitab to analysis data, generated appropriate plots/graphs required to show performance against acceptance criteria for DV reports
• Ability to write and get cross functional support for engineering rationales used to support product development activities
• Demonstrated ability to execute Design Verification testing, including building samples, adherence to test protocols/test methods, responsible data collection/preparation practices, and good lab practices.
• Demonstrated ability to clearly and effectively communicate (verbal & written) concepts and ideas to technical and non-technical team members in a way that articulates problem statement, investigating approach, possible solutions, final recommendation, and implementation plan
• Strong decision-making capability, even with limited or ambiguous information with the ability to absorb information and solve complex problems quickly
• Demonstrated industry or academic experience driving product development in a cross functional team setting to solve complex problems and meet milestones
• Works with self-direction, takes initiative, exercises sound judgment, discretion, and capable of complex decision making in a dynamic work environment

Minimum 6 years of experience as a product design / development engineer in the medical device, pharmaceutical or other regulated industry (experience with FDA class II or III medical devices preferred). Bachelor’s degree required in Mechanical or Biomedical Engineering (Mechanics focus). Master Degree or above preferred.