Senior Manufacturing EngineerExton, PAOn-SiteThe Senior Manufacturing Engineer 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. They will lead the implementation of the project to production.At dsm-firmenich people are at the heart of the company. We are committed to equal employment opportunities and value diversity in the workplace.Key Responsibilities:Evaluate, identify, and implement improvements to solve quality, productivity, and safety problems in our polyurethane processing area.Lead effort to collect relevant data and drive machine reliability improvements.Use good root cause analysis, DOE, and statistics knowledge to troubleshoot equipment and process issues and then implement improvements.Scope and justify new capital equipment to support process improvements and capacity increases.Support business compliance through NCR, CMP, CAPA, and IRIS completion.Develop all necessary documentation (MOC, IQ/OQ/PQ, ECR/ECO, and procedures) to support process changes.We Bring:A competitive compensation package, with comprehensive health and welfare benefitsA 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 field5-8 years of experience in Medical Device or related industryProficient in the use of MSOffice, Word, Excel, PowerPoint, MS Project, Minitab, CAD Software, and SharePointExtensive experience of chemical and melt processing techniques (i.e. machining, injection molding, extrusion, sterilization), manufacturing machinery and toolingExtensive knowledge of medically useful biomaterials (bio-resorbable and non-degradable)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 standardsExtensive knowledge of electrical wiring schematics, electrical diagrams as well as PLC & PC programmingLean Six Sigma Green Belt certification preferredKnowledge and experience with leading technology, application and implementation of manufacturing automation, robotics anddata exchange in manufacturing technologies (Industry 4.0)dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drives unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate: there's a place for everyone at dsm-firmenich.dsm-firmenich is an Equal Opportunity and Affirmative Action Employer. dsm-firmenich people are as diverse as our customers. For us that includes a commitment to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable to share this, please let us know.#ext
