Manager, Mechanical Engineering, R&D (Hybrid)

Insulet Corporation-posted about 2 months ago

Full-time • Manager

Hybrid • Acton, MA

5,001-10,000 employees

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The Manager, Mechanical Engineering will help drive innovation and leadership within its Hardware Engineering team. They will manage a team of talented mechanical engineers, fostering innovation, collaboration, and technical excellence. This role balances strategic leadership with hands-on technical guidance to drive the development of high-performance mechanical solutions across the product lifecycle. Success depends on a strong understanding of engineering and scientific fundamentals as well as experience with leading a team through end-to-end product design in the medical device environment.

Talent Development : Attract, mentor, and retain top mechanical engineering talent to deliver high-quality, innovative products to patients worldwide.
Design Leadership : Guide the design and development of complex mechanical components and assemblies, ensuring robust, manufacturable, and cost-effective solutions.
Technical Excellence : Drive best-in-class mechanical design methodologies, including tolerance analysis, material selection, DFM/DFA, and CAD modeling.
Lifecycle Management : Oversee design changes, risk assessments, and design transfer activities to ensure smooth transitions from development to manufacturing and market launch.
Post-Market Support: Support root cause investigations, CAPA execution when necessary.
Compliance & Documentation: Ensure design documentation meets regulatory and quality standards, including traceability of design inputs/outputs, verification/validation, and risk management.
Continuous Improvement: Champion process improvements in mechanical design workflows, tools, and standards to enhance quality, efficiency, and compliance.

Proven ability to lead and develop high-performing technical teams, mentor peers, and foster a culture of innovation and continuous improvement.
Strategic thinker with strong decision-making skills, capable of translating product requirements into scalable manufacturing solutions and driving clarity in ambiguous, fast-paced environments.
Skilled communicator and collaborator across engineering, operations, and vendor teams, with a demonstrated ability to influence decisions and outcomes across organizational boundaries.
Bachelor of Science in Mechanical Engineering or Biomedical Engineering.
Master's Degree Preferred.
BS degree: Minimum of 8 years of product design and development experience, preferably medical device class II or III.
MS degree: Minimum of 6 years.
Minimum of 4 years of leadership experience, which may include roles: managing direct reports, technical lead or project lead, in which candidate lead engineers.
Demonstrated experience in: Design of disposable, biocompatible, medical devices.
Authoring design inputs, verification/validation protocols, and reports in compliance with ISO 13485, ISO 14971, and FDA 21 CFR Part 820.30
Change management, risk analysis, and design transfer
CAPA execution, failure analysis, and post-market support
Experience with electromechanical devices (PCBA, batteries, interconnects, layout), a plus
Experience in high volume product design ( >10 million units per year), a strong plus
Ability to organize and judge priorities, as well as oversee and delegate responsibilities to other engineering staff / team members
Ethical, responsible, and data-driven decision-maker
Ability to effectively communicate (verbal/written) at multiple levels of an organization
Strong foundation in mechanical engineering fundamentals and first principles
Knowledge and experience in design of experiments (DOE) and medical device V&V
Knowledge of Statistical Process Control (SPC), GD&T
Knowledge of Design for manufacturing/cost (DFM/C)
PC skills - MS Office Suite, SolidWorks, and ePDM

Experience in high volume product design ( >10 million units per year), a strong plus
A track record of generating novel ideas / IP, a strong plus
Knowledge of infusion pumps and subcutaneous injection systems, a strong plus
Experience with electromechanical devices (PCBA, batteries, interconnects, layout)
Ansys, MATLAB, LabVIEW experience
Six Sigma training or certification

Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs

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Manager, Mechanical Engineering, R&D (Hybrid)

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