Engineer II Manufacturing, New Process Introductions (NPI) - Exton, PA

Engineer II Manufacturing, New Process Introductions (NPI)

Exton, PA

The Engineer II Manufacturing, New Process Introductions (NPI) will provide technical support, tooling and equipment design, and processing expertise towards process development, scale up, and commercialization for new and existing product lines. This role will collaborate closely with Research, Commercialization, and Quality teams to develop and enhance current and future products and processes. The Manufacturing Engineer II, New Process Introductions (NPI) will also participate in project teams within the PMP/project management process.

Join our innovative engineering team as a Manufacturing Engineer and play a key role in driving New Process Introductions (NPI) at our state-of-the-art Biomedical Facility. Be part of a mission that bring innovation and progress to life. 

Key Responsibilities:

• Support process development, process characterization, scale up and commercialization of new products/processes from lab and pilot scale to high volume manufacturing.
• Assist in continuous improvement initiatives to optimize productivity, yield, cycle time, and overall operational efficiency
• Develop and manage project plans for process development activities to generate critical process design information for scale-up and evaluate process technical risks.
• Recommend and specify process equipment, define sizing requirements, contribute to equipment procurement and fabrication, and identify instrumentation, controls and automation requirements
• Update product /process documentation within the Engineering Change Notice process.
• Participate in dsm-firmenich PMP Silver base projects
• Support Manufacturing Excellence (MSA, OEE, IP, IER, and DICI)
• Review & approve MOCs & ECNs
• Review, disposition, & approve non-conformance reports, deviations, rework orders, engineering test files (ETF), design control & risk management reports.
  
  

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:

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Chemical, Materials, or related field).
• A minimum of 2-6 years of process engineering experience in the Medical Device industry or related field. Experience in an industrial R&D environment will also be considered.
• Proven ability to implement process improvements and scale technologies from lab or pilot scale to full commercial production is highly desirable.
• Hands-on experience in industrial-scale process development and characterization is strongly preferred.
• Significant experience working with manufacturing equipment and conducting process validations (IQ, OQ, PQ) in cleanroom or controlled environments is highly preferred. 
• Proficient in the use of MS Office, Word, Excel, PowerPoint, MS Project, Minitab, CAD Software, and SharePoint.
• Demonstrated project management experience. Ability to apply Project Management techniques according to PMP.
• Extensive experience of chemical and melt processing techniques (i.e. machining, injection molding, extrusion, sterilization), manufacturing machinery and tooling.
• Solid knowledge of medically useful biomaterials (bio-resorbable and non-degradable).
• Strong expertise in applying Engineering & Quality tools (Statistics, Lean Six Sigma, DFM, DOE)
• Proficient in regulatory pathways including IDE, 510(k), PMA, and CE marking, with working knowledge of relevant ISO and ASTM standards.  
• Lean Six Sigma Green Belt certification preferred.