Product Development Engineer

Millenniumsoft•Baltimore, MD

1d•Remote

About The Position

Seeking a candidate with product development experience working with cross-functional teams. This role will provide solid technical skill and engineering support for design and development activities for new and existing products. The engineer will support current products in terms of quality, manufacturing, supply continuity and cost improvement. They will participate in executing technical and/or cross-functional project work and contribute to a culture of innovation by proactively generating novel concepts for new products and enhancements to current product performance. The candidate will understand customer needs through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated use studies. They will also 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.

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
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.
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.

Nice To Haves

Experience with ISO13485, 21CFR820, and ISO14971 favorable.

Responsibilities

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.