Manufacturing Engineering Manager - Exton, PA

Manufacturing Engineering Manager

Exton, PA

The Manufacturing Engineering Manager 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.

At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work to not only benefit our People, Customers & Communities but also drive business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated. 

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. 
• Lean Six Sigma Green Belt certification preferred.
• Demonstrated project management experience. Ability to apply Project Management techniques according to PMP. DSM PMP Silver training required. External PMP certifications preferred.
• 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 manufacturing machinery and tooling in a medical device environment or related industry.
• Extensive knowledge and experience working with Engineering & Quality tools (Statistics, Lean Six Sigma, DFM, DOE).
• Knowledge and experience working with the Regulatory pathways associated with IDE, 510k, PMA, & CE including the associated ISO & ASTM standards.
• Broad and comprehensive knowledge of engineering theories, concepts and practices with the ability to use these in complex, difficult and/or unprecedented situations.
• Excellent analytical, problem solving and decision-making skills to choose the best solution and solve problems as decisions may have major implications.
• Accuracy, a detail orientation, initiative to multi-task with deadlines, flexible can-do attitude, and ability to adjust workload to meet varying schedules.
• Industrial scale hands-on experience with process optimization focus.
• Understanding of financial and accounting requirements in projects