Engineer II, Manufacturing - Exton, PA (United States) at Our Company
Our Company · Exton, United States Of America · Onsite
- Professional
- Office in Exton
Engineer II, Manufacturing
Exton, PA
The Engineer II Manufacturing will provide technical leadership, machine design, and processing expertise towards the process development, scale up, and commercialization for new and existing product lines. They will be leading a large team of Research, Commercialization, & Quality Engineers tasked with developing and/or improving current and future dsm-firmenich Biomedical products/processes. They will direct or participate on project teams within the PMP/project management process and will lead the implementation of the project to production.
Key Responsibilities:
- Evaluate, identify and recommend/implement improvements (productivity, efficiency, reliability) to existing processes (melt processing, chemical, machining or mechanical) or products.
- Create and/or process ECN’s, process routers, drawings, and other written documentation in accordance with GMP requirements to support product development, process development, validations and manufacturing.
- Conducting investigations and implementation of improvements into manufacturing product/processing issues.
- Support Operations to address plant layout, resources, and start up milestones and in the daily manufacturing of commercial products.
- Conducting investigation into customer complaints and resolution as it relates to manufacturing process, equipment or product requirements
- Directing or participating in a variety of projects with cross-functional project teams. Collaborating with Strategic Business Innovation, Strategic Business Management, Research & Development, Quality, Regulatory, Safety, Finance, & Manufacturing groups.
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.
- 2+ years of experience in Medical Device or related industry; extensive knowledge of medically useful biomaterials (bio-resorbable and non-degradable).
- Excellent oral and written communication skills to provide information to others by telephone, in written form, e-mail, or in person.
- Ability to lead and/or function as part of a team.
- 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. dsm-firmenich PMP Silver training preferred
- Extensive experience of chemical and melt processing techniques (i.e. machining, injection molding, extrusion, sterilization), manufacturing machinery and tooling.
- Extensive knowledge and expertise working with Engineering & Quality tools (Statistics, Lean Six Sigma, DFM, DOE).
- Working knowledge and experience working with the Regulatory pathways associated with IDE, 510k, PMA, & CE including the associated ISO & ASTM standards.
- Extensive knowledge of electrical wiring schematics, electrical diagrams as well as PLC & PC programming.
- Lean Six Sigma Green Belt certification preferred.
- Broad and comprehensive knowledge of engineering theories, concepts and practices with the ability to use these in complex, difficult and/or unprecedented situations.
- Industrial scale hands-on experience with process optimization focus. Ability to identify process improvement opportunities and design experiment in the Lab to evaluate opportunities.
- Knowledge and experience with leading technology, application and implementation of manufacturing automation, robotics and data ex Knowledge and expertise of products/processes used in medical device environment.
- Knowledge and experience working with manufacturing machinery and tooling in a medical device environment or related industry.
- Knowledge and experience with leading technology, application and implementation of manufacturing automation, robotics and data exchange in manufacturing technologies (Industry 4.0).