Process Engineer I​/II

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About Organogenesis:
We are a leading regenerative medicine company in the advanced and acute wound care space, focused on therapies for chronic and acute wounds. Our portfolio includes skin substitutes and other regenerative medicine products designed to empower patients with life-changing solutions.

The Process Engineer II role is part of the Process Engineering department, responsible for developing, implementing and maintaining robust and efficient manufacturing processes for new and existing medical devices and pharmaceutical products. The role works closely with Manufacturing, Product Development, and Quality teams to ensure processes are validated and controlled according to ISO 13485, FDA and other regulatory requirements. The position will drive continuous improvement projects to enhance product quality, reduce costs and improve manufacturing efficiency.

• Specify and procure new capital equipment, overseeing installation and qualification protocols
• Design, develop and implement new manufacturing processes, equipment, tooling and fixtures for new product introductions
• Conduct process simulations and analyze data to identify inefficiencies, reduce cycle times and minimize scrap
• Assist in development and execution of process validation protocols to ensure processes consistently meet quality standards
• Support internal and external audits by providing documentation and expertise on manufacturing processes
• Conduct process risk assessments, such as PFMEA, to identify and mitigate potential risks to product quality and patient safety
• Support the transfer of processes and products from development to commercial manufacturing, facilitating successful scale-up
• Prepare engineering drawings, specifications, protocols and reports for internal use and regulatory submissions
• Support all manufacturing systems, current and new

• Bachelor’s Degree in Chemical/Bio-Medical Engineering or equivalent with 2 to 5 years’ experience
• Ability to work on multiple projects simultaneously
• Experience in GMP environment/medical device industry with knowledge of 21 CFR Part 820, ISO 13485 and FDA biologics requirements
• Ability to read, write and comprehend English
• Good computing skills including Microsoft Office
• Strong communication, interpersonal, and presentation skills for working with diverse teams and management
• Ability to solve practical problems both individually and in a team environment
• Ability to work independently with minimal supervision
• Knowledge of GMP, GAMP guidelines, IEEE specifications, ISA specifications, ASTM specifications and batch process control in the life science industry
• Working knowledge of Solid Works and AutoCAD is desirable
• Experience in medical device design and application of test standards
• Ability to read, write functional requirement specifications, follow verbal instructions, interpret technical procedures, and technical writing skills
• Experience working in a hands-on environment and building/setting up equipment
• Understanding of PLCs; familiarity with manufacturing automation systems is helpful
• Ability to read standard electrical diagrams and logic schematics

• 401k — generous employer match with immediate vesting and financial planning resources
• Comprehensive Medical, Dental and Vision coverage from day one
• Flexible Spending Account or Health Savings Account
• Company-paid insurances including Short Term, Long Term and Life insurances with voluntary options
• Paid maternity leave and parental leave for all new parents
• Adoption benefits
• Education Assistance Policy − $5,000 per year for all employees
• Wellness Program with mental health resources, mindfulness and on-site flu shots
• Employee Assistance Program
• Generous paid time off including vacation, floating holidays, sick days, and company holidays
• Free parking with electric charging stations (Canton and La Jolla)
• Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint

We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law. We do not accept unsolicited agency resumes and are not responsible for any fees related to unsolicited resumes.

• Seniority level:
  Entry level
• Employment type:
  
  Full-time
• Job function:
  Management and Manufacturing

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