Product Development Engineer

Position: Product Development Engineer

Location: Sparks, MD

Duration: 9+ Months Contract

Total Hours/week: 40.00
pay range -$25-30/hr

Client: Medical Device Company

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

No H1B’s

Temp worker
Remote capable
Traditional work hours (8-4, 9-5)

Description:

Requirements: BS in Biological/Chemical sciences or engineering, product development experience (at least 2 years), in vitro diagnostic experience, requires minimal oversight, comfortable with fast-paced environments

Must have: understanding of design controls, experience in FDA/ISO regulated environments, cross-functional team experience, understanding of international regulations and standards. Team oriented, collaborative, data driven, with the ability to interpret data, root cause analysis, and detail oriented.

Seeking candidate with product development experience working with cross-functional teams. Experience with ISO13485, 21CFR820, and ISO14971 favorable.

Provide solid technical skill and engineering support for design and development activities for new and existing products.

Support current products in terms of quality, manufacturing, supply continuity and cost improvement.

Participate in executing technical and/or cross-functional project work.

Contribute to a culture of innovation by proactively generating novel concepts for new products and enhancements to current product performance.

Understand customer needs through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated use studies.

Review/write detailed technical reports based on design verification analysis/testing for design changes and product design activities.

Ensure compliance with BD quality policies, procedures and practices as well as with all local, state, federal and BD safety regulations, policies and procedures.

BS degree in Biology, Chemistry, Biochemistry or Engineering is required.

0-2 years of experience is required, preferably in medical device product development. Demonstrated ability to utilize statistical tools and computer analysis.