Chemical Engineer, NPI & Transfers

$-$ (Financial compensation packages may be higher/lower than listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)

Responsible for supporting process development and improvements for medical devices for both existing and new product development, production, and processes. This includes working closely with R&D at the early phases of product development to create manufacturing specifications, maintain and enhance product processes, design fixtures and equipment, test processes, equipment, validate test methods, and select raw materials to ensure that concepts and prototypes meet their specifications.

Support projects related to new product introductions, existing process improvement and engineering to improve product quality and yields, and other engineering tasks. Evaluate, initiate, and establish improved engineering and project systems for procurement and execution of process validation. Work with Manufacturing, Quality, Regulatory, and global Marketing teams internally and outside vendors and consultants.

• Develop new processes and perform process characterization and optimization.
• Support improvement for existing processes, new products, product changes, line extensions, enhancements, and related tooling and fixtures.
• Work closely with R&D team to design manufacturability and assembly into the product (DFMEA).
• Characterize process and determine critical process parameters by applying statistical tools such as DoE and ensure readiness for process validation.
• Apply statistical process control techniques to establish review and refine control limits for existing processes.
• Support validation of product, equipment, and process.
• Collaborate with other departments to ensure readiness for process validation.
• Draft and execute validation of product, equipment, and process.
• Evaluate, create, and initiate improvements to existing engineering and project systems.
• Analyze test data using statistical tools (e.g., Minitab) to inform leadership decisions for enhancing existing processes and improving product quality and yield.
• Manage builds for new product development in prototype and pilot production settings, including training of operators and coordination with production planning.
• Plan and execute root cause investigations related to product and process failures.
• Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop process.
• Set up and initiate new manufacturing line(s), including purchasing, implementing, and validating new equipment (IQ/OQ/Q).
• Support Design Transfer and Line Transfer activities to different manufacturing sites.
• Review and develop manufacturing documents (e.g., MP, BOM, pFMEA, etc.).
• Develop documentation expertise in equipment mechanical design and manufacturing process.
• Seek and implement innovative technologies to enhance manufacturing processes and equipment design.
• Help establish systems for monitoring production processes to identify inefficiencies and develop strategies to reduce waste, improve yield, and enhance product quality.
• Lead, mentor, and support Engineers, Technicians, or others as needed.
• Comply with applicable laws and regulations, adhere to Quality Management System processes and requirements as well as demonstrate ethics and integrity in all matters and at all levels throughout the organization.

• Bachelor's degree in Mechanical, Manufacturing, Chemical, Industrial Engineering or related field.
• Minimum six (6) years of relevant manufacturing process development experience in the medical device and/or pharmaceutical industry.
• Strong written and verbal communication skills.
• Proficient computer skills including MS Word, Excel, Outlook, Teams.

• Advanced degree in Engineering or related field.
• Minimum eight (8) years of relevant manufacturing process development experience in the medical device and/or pharmaceutical industry.
• Proven ability to design, develop, and validate manufacturing processes of medical devices and working knowledge of cGMP.
• Knowledge of statistical tools including Design of Experiments (DOE) and Cpk for process development, characterization, and optimization.
• Knowledge of process design, optimization and validation (IQ, OQ, PQ).
• Familiarity with statistical tools such as Minitab.
• Proven knowledge of Lean/Six Sigma techniques (Green or Black Belt plus).
• Ability to solve complex manufacturing problems.
• Demonstrated ability to improve process capacity and yield.
• Ability to read and prepare technical documentation.
• Knowledge of medical and technical development as well as international regulations for medical devices.
• Strong problem solving and conflict management skills.
• Proficiency with Solid Works and fixture design.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for…