Development Engineer

Net2Source (N2S); Warsaw (IN); On-site; USD 48,000 - 55,000; Full time

Job summary

Net2Source Inc. is seeking a biomedical device design professional for new product development and market sustaining activities. The role emphasizes translating surgeon/user needs into robust design inputs and verifiable outputs while ensuring compliance with global regulations.

You will collaborate with cross-functional teams to guide design transfers, validation, and production documentation for market release quantities across global operations.

Qualifications

• Minimum B.S. degree from ABET-accredited school in engineering.
• Experience in medical device product design and development preferred.
• Familiarity with design control and risk management processes.

Responsibilities

• Stays current with arthroplasty product use, procedures, regulations and standards.
• Translates user needs into design inputs meeting market needs and compliance.
• Creates product designs with documented design rationale.

Skills

Product design

Regulatory compliance

Design verification

Risk management

Education

ABET-accredited B.S. in Mechanical Engineering or related fields

Job description

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.

Company: One of Our Clients

Job Description:

Location: Warsaw, IN 46580 (100% onsite)

Duration: 12+ Months (Extendable)

Pay rate: $35.00 – 40.00/hr on W2

2 openings

Description:

You have a key support role with responsibility for new product design, development, and commercialization; and/or to maintain in the market innovative medical device products in order to further client’s mission and grow client’s market leadership position.

Principal Duties and Responsibilities:

• With oversight from supervisor and mentorship by senior peers:
• Stays current with and understands relevant arthroplasty product intended use, clinical procedures, and related regulations and standards.
• Identifies user needs through engagement with product users (often Orthopedic Surgeons) and observation of similar device usage.
• Translates targeted user needs into design requirements/inputs which satisfy unmet market needs to achieve business goals while also complying with global regulatory requirements and recognized external industry standards.
• Creates product designs which fully address targeted user needs/requirements, and authors design rationale to document basis of all design features.
• Prepares and reviews information for invention disclosures and patents.
• Initiates, provides instruction for and coordinates with support from client’s cross-functional team members in the production and inspection of product prototypes for preliminary evaluation; and final design verification, design validation and process validation
• Creates product production specifications which appropriately account for design for manufacturability (process capability) and inspection.
• Identifies and documents critical to quality product features based on product intended use, design requirements, associated user risks and the design itself to ensure appropriate quality control inspection plans are generated.
• Evaluates, verifies and validates product designs relative to design requirements and to reduce user risk in compliance with procedures and global regulatory requirements (includes completing tolerance stack-ups, benchtop testing and executing simulated operating room cadaveric product evaluations)
• Authors, presents and obtains cross-functional team member approval of design control and risk management documentation as part of the product development process in compliance with client’s procedures and global regulatory requirements
• Supports client’s Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities

Education:

Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering.

Awards and Accolades:

America's Most Honored Businesses (Top 10%)

Awarded by USPAAC for the Fastest Growing Business in the US

12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)

Fastest 50 by NJ Biz (2020, 2019, 2020)

INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)

Top 100 by Dallas Business Journal (2020 and 2019)

Proven Supplier of the Year by Workforce Logiq (2020 and 2019)

2019 Spirit of Alliance Award by Agile1

2018 Best of the Best Platinum Award by Agile1

2018 TechServe Alliance Excellence Awards Winner

2017 Best of the Best Gold Award by Agile1(Act1 Group)