Manager, Engineering - Exton, PA

Manager, Engineering

Exton, PA

The Manager, Engineering will provide purpose, direction, and motivation while operating to accomplish the goals and improving the Manufacturing Engineering Group. They will provide guidance and expertise towards the final stage development, scale up, and commercialization of new and existing product lines and tooling for Polymer, Device and Natural Material COE’s. They will be managing a team of Engineers and Technicians tasked with developing and/or improving current and future dsm-firmenich Biomedical materials-based machinery/tooling and products/ processes. They will direct or participate on project teams within the PMP/project management process. This position manages product lifecycle support for running business. This position evaluates and investigates new technologies and potential relationships with outside companies’ products in support of the Strategic Business Initiatives.

Key Responsibilities:

• Manage evaluation of scale up options, selection, & implementation by leading projects, providing project updates, and offering input for the next phases.
• Manage evaluation of potential new product/ process proposals and provide recommendations as to the scope and necessary timing required for specific production targets.
• Develop and review project plans, cost estimates, schedules, and resource requirements.
• Lead Manufacturing Reviews of new products and process improvements.
• Cultivate a team with the expertise to provide in-house development and/or technical leadership to Research & Development, Commercialization, and Operations Groups.
• Manage continuous improvement of products/ processes to achieve improvements in productivity, yield and/or operating costs.
• Manage annual goals/objectives.
• Perform Personal Development Reviews (PDR) on direct reports, fostering individual growth and development.
• Manage the preparation of applicable technical sections of regulatory documents (FDA 510k, IDE, PMA, CE), grants, & patent filings.
• Execute the job within the applicable DSM, OSHA, EPA, ISO, FDA, CE, & other requirements.

We Bring:

• A competitive compensation package, with comprehensive health and welfare benefits.
• A place to grow and develop.
• A company that is purpose-led and performance-driven in a corporate culture that values people and planet.
• The opportunity to work on growing brands and build on a strong foundation.
• The chance to make improvements and make an impact on the business.

You Bring:

• Bachelors or Master’s degree in Engineering — Biomedical, Mechanical, Electrical, Chemical, Materials or related field. Master’s degree in Business is beneficial.
• A minimum of 7 years of experience in Medical Device or related industry; extensive knowledge and experience working with manufacturing machinery and tooling in a medical device environment or related industry.
• Extensive knowledge and experience working with products/processes used in medical device environment.
• Excellent interpersonal skills to interact and communicate effectively with all levels of personnel.
• Ability to lead & manage and/ or function as part of a multifunctional and multi- departmental team.
• Proficient in the use of MSOffice, Word, Excel, PowerPoint, MS Project, IYlinitab, and SharePoint.
• Extensive knowledge and experience working with Engineering & Quality tools (Statistics, Lean Six Sigma, DFM, DOE); Lean Six Sigma Green Belt certification preferred.
• Knowledge and experience working with the Regulatory pathways associated with IDE, 510k, PMA, & CE including the associated ISO & ASTM standards.