Lead Mechanical Engineer - Medical Device New Products - United States
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- We are seeking a Lead Mechanical Engineer who will report to the R&D Manager of New Products for Diabetes Care.
- The Lead Engineer will bring advanced engineering skills, to R&D activities related to new single use disposable products.
- The candidate will play a lead role in designing of single use plastic injection products for diabetes therapy.
- Candidates should be prepared to present previous product engineering work during the interview process to demonstrate their abilities and experience.
Duties and Responsibilities
- Lead the design efforts for single use disposable products. The candidate will be responsible for identifying, developing and delivering innovative and practical solutions in alignment with the product development road map.
- Lead the group, working with Marketing, in the next generation injection systems by understanding the customer needs and translating them into functional engineering solutions to design safe and effective single use disposable products for injection.
- Lead the efforts in creation of specifications, design, and test methods for the new products.
- Interface with manufacturing on an ongoing basis during the development stages to ensure manufacturability of the design solutions.
- Support the design for pen needles and syringes.
- The Lead Engineer would collaboratively interface/influence manufacturing associates on a frequent basis to provide technical guidance on issues that affect DFMA, manufacturing capability and rate of the NEW products in the pipeline.
- Facilitate and/or coordinate clinical and formative studies- to develop scope definition, design response correlations and design solutions.
- Must have a BS in Engineering (Mechanical (preferred), or Biomedical engineering) with at least 8 years experience, preferably in high volume and /or medical device industry developing new products
- Must have strong design skills in single use plastic and/or metal disposable products with at least 5 years’ experience using Solidworks.
- Experience leading teams without authority cross functionally.
- Experience working in structured Phase Gate product development and technology development processes.
- Proficient in Microsoft office products with emphasis on Excel, and Word.
- Ability to lead new product development activities including conceptualization and design controls (design verification, validation, process validation etc.).
- Ability to clearly communicate ideas and knowledge (upward and downward) to other individuals and teams – both in writing and verbally.
- Must have strong project management and experience working with outside design services.
- This should include experience managing budgets, timelines, design scope and manufacturing activates.
- Experience managing multiple work streams.
- Experience in developing vendors and partners.
- Travel- 10-15% domestic or international travel