Design Transfer Lead Engineer

This is a hybrid position but at times, 100% onsite will be required for stretches of work.

Job Description:
The Senior Engineer position within the Science and Technology (S&T) organization is responsible for the development, improvement, and verification of electro-mechanical medical devices. This technical expert will, with little supervision, primarily apply engineering knowledge and ingenuity in the execution of design improvements.

Responsibilities:

• Manage device design changes by interfacing with cross-functional teams both at manufacturing partners and within the client. Team member has full awareness of the potential consequences (defects and failure modes) of design changes to electromechanical drug delivery devices. Mitigates risk through strong technical acumen, detailed planning, and engineering confidence testing.
• Verification testing (planning, fixture development, test method validation, protocol development, and test execution). The team member will be responsible for multiple, often concurrent, projects including those involving external development partners.
• Propose device refinements based upon patient feedback, manufacturing records, and feedback from other stakeholders.
• Conduct analyses (e.g. calculations, tolerance analysis, etc.) as needed to improve product and component designs.
• Lead and/or participate in root cause investigations and design solutions for complex engineering problems.
• Responsible for compliance with applicable procedures, regulations, and standards (e.g. IEC 60601-1:2020, ISO 10993-1:2018). Ensures quality and effectiveness of projects through sound design, early risk assessments, and implementation of fallback strategies.
• Maintains device history file
• Some travel may be required

Qualifications:

• Bachelor s Degree in Engineering with a desired 8+ years of significant engineering experience. A post-graduate education / degree is desired and may contribute towards the desired years of experience.
• Has a career history marked by a consistent series of technical contributions and accomplishments.
• Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
• Proficient in SolidWorks

What are the top 3-5 skills, experience or education required for this position:
1. Design Verification of electromechanical devices
2. Infusion pump or on body infuser development or sustaining engineering experience
3. Authoring of test plans, protocols, and reports
4. Good documentation practices
5. Cross-functional collaboration

The benefits that you are eligible for with Collins Consulting, Inc:

• 401(k)
• Medical, Dental and Vision Insurance
• Term Life Insurance
• Accidental Death and Dismemberment
• Long Term Disability