Process Engineer I/II

About Us

We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our strength is giving others strength.

Learn more about Careers at Organogenesis

What You Will Achieve:

The Process Engineer II role is part of the Process Engineering department, and will be responsible for developing, implementing and maintaining robust and efficient manufacturing processes for new and existing medical devices and pharmaceutical products. This 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.

How You Will Achieve It:

• 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.
  
  
  

What You Need to Achieve It:

• Bachelor’s Degree in Chemical/Bio-Medical Engineering or equivalent with 2 to 5 years’ experience
• Ability to work on multiple projects simultaneously.
• Experience working in a GMP environment/medical device industry and ensure 21 CFR Part 820, ISO 13485 and FDA biologics requirements are met.
• 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.
• 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 SolidWorks and AutoCAD Software is desirable.
• Experience using AutoCAD and/or Solidworks
• 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 beneficial.
• Experience working in a hands-on environment.
• Experience building and setting up equipment.
• Understanding of PLC’s would be helpful but not required.
• Familiarity with manufacturing automation systems is helpful but not required.
• Ability to read standard electrical diagrams and logic schematics.
  
  
  

What can we offer you?

• 401k -- generous employer match with immediate vesting and financial planning resources
• Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
• Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
• Company paid insurances including Short Term, Long Term and Life insurances as well as 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 including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
• Employee Assistance Program
• Generous paid time off including vacation, floating holidays, sick days, and company holidays
• Free parking including an electric charging station (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 we are not responsible for any fees related to unsolicited resumes.