The
Principle Development Engineer is responsible for the
development of new products for a medical device product line (up to $100M in sales). This position will also provide support to current product lines, which include disposable, plastic lines. Responsibilities will include but are not limited to concept development, product design, product performance testing, verification and validation, and transfer to manufacturing. The chosen candidate must be able to work in a team environment and be able to communicate clearly across all disciplines.
The position requires a hands-on engineer who will be both responsible for collaborating with the marketing team on identifying
improvement opportunities and
unmet customer needs as well as working with manufacturing and/or procurement to identify partner and process selections.
Specific responsibilities include:Team Leadership – Key Functional Leader representing the R&D group for large New Product Development Programs. In this role, the engineer will serve as the liaison between the Program Manager, R&D Functional Manager and Extended Team Members.
- Provide effective and timely prioritization and day to day tactical guidance & technical direction to extended team members within the R&D function. Identify and resolve short and long term resource constraints.
- Identify technical risks up front and develop and execute mitigation plans and provide team with direction on how to remove or avoid roadblocks.
- Build strong relationships with Marketing and Sales partners to understand product application, market dynamics, current strengths and future opportunities.
- Project Leadership – responsible for leading cross-functional teams for smaller platform projects.
- Provide effective technical day to day support for product lines under scope of responsibility. This includes timely response and good customer service for procurement and the manufacturing plants.
- Some travel will be required, including that outside of the United States.
REQUIREMENTS:BS in Mechanical, Biomedical, or Plastics engineering desired. MS or BS+MBA preferred
At least 1 year of
Medical Device or FDA industry requirements desired
Minimum of 8+ years of related professional work experience
Experienced in
New Product Development with proven results.
Advanced leadership, problem solving, decision making and presentation skills.
Knowledge of
Design Controls and experience working within a structured
stage gate PDP Process (specific to Medical Products or Medical Device Industry)
Knowledge of Validation and Verification including Testing of medical devices
Strong proven statistical analysis capabilities are required and Six Sigma training a plus.
Additional experience in Manufacturing and Automation is a plus