(Sr) Production Engineer, Device Manufacturing (RI)

Job Description
Semma Therapeutics, a biotechnology company focused on developing a stem cell-based cell therapy for Type 1 diabetes, is seeking a Senior Production Engineer to join its growing team. The full-time role will support device manufacturing activities of Semma’s cell encapsulation device platforms. The Production Engineer will be responsible for developing and optimizing processes in manufacturing. The successful candidate will have a good understanding of the medical device field, GMP manufacturing, CMC activities, knowledge of DOE methodology, equipment and process qualifications and automation. The position is in Providence, RI and will report to the Director of Device Manufacturing.

Responsibilities:

  • Develop and implement manufacturing processes from pre-clinical through clinical phases and launch
  • Lead development of fixtures, equipment and automation, installation and Commissioning of assembly equipment
  • Lead review of CMC (Chemistry Manufacturing Controls) and implement specialty coating application
  • Conduct process evaluations and lead process optimization initiatives utilizing tools such as SPC, DOE, PFMEA and, MSA
  • Identify, evaluate and manage vendors and implement supplier controls
  • Develop and lead projects to improve efficiency, quality and reduce costs
  • Conduct root cause failure analysis and corrective action
  • Establish sampling plans / Quality plans/ Metrology methodology
  • Participate / lead risk management activities including FMEA
  • Identify product failure modes and provide possible solutions through product and process modifications
  • Participate / lead verification and validation activities for design, process or products
  • Development and qualification of test methods for verifications and validations
  • Support design control and risk management activities

Required qualifications:

  • MS in Engineering, Material Science or related discipline
  • Over 5-10 years industry experience working in medical or implantable biomedical devices
  • Demonstrated knowledge of biomaterials, coatings, chemistry, process development and device manufacturing
  • Working knowledge of FDA and other applicable medical device and combination product standards
  • Ability to communicate effectively with a diverse range of scientists, physicians, engineers, regulatory specialists and business professionals
  • Demonstrated excellence in planning, executing, and project management
  • Authorized to legally work in US

Preferred qualifications:

  • PhD in Engineering, Life Sciences or related discipline
  • Deep understanding of the chemical properties of polymeric materials, biomaterials and coatings
  • Familiarity with polymer synthesis, molding and assembly methodologies
  • Experience in combination products, preferably delivering living cells
  • Experience operating under design control and GMP manufacturing
  • Ability to manage projects, process development and CMC activities through timelines to meet corporate goals

Please note that applicants should have authorization to work in the United States. Semma offers competitive pay, health insurance, time-off among other benefits. Please, fill out the form below and include your resume.

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