Process Engineer III
Job Req code: 939
Organogenesis corporate headquarters is located in Canton, Massachusetts, including manufacturing, R&D, customer service, reimbursement and other corporate teams supporting our full range of products. We have unique opportunities 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.
The Process Engineer III role is part of the Process Engineering department, which supports all aspects of the manufacturing process from supply chain to shipment. The team assists in product design, development, and is responsible for developing and testing solutions to solve a wide variety of technical problems.
The Process Engineer III will serve as a Subject Matter Expert (SME)/lead for packaging materials and other engineering tasks as required. The individual will provide technical expertise regarding experience designing packaging for medical devices and consumables as well as experience with cold chain shipping. The position will use process knowledge to successfully plan, design packaging for medical equipment and consumables, including cold chain shipping. As a core team member of the Process Engineering department, the Process Engineer III will oversee/monitor the work of others, including contractors, and will mentor junior team members. The role will participate in projects to improve product yield, increase capacity, and/or reduce overall production cost. The projects will support all manufacturing systems, current and new.
A successful candidate will be an independent self-starter, who can work with minimal direction and takes ownership of a job from concept through manufacturing/implementation. The successful candidate will be highly motivated and creative.
- Bachelor’s Degree in Mechanical Engineering or equivalent with a minimum of 5 to 7 years relevant work experience.
Demonstrated working experience with development and testing of containers and plastic packaging materials (trays, pouches, etc.).
Experience managing projects with outside vendors and/or contract manufacturers.
Demonstrated working experience with multi-tasking, prioritizing, and managing multiple projects.
Experience working in a GMP environment/medical device industry.
Familiarity with ISTA/ASTM packaging tests.
Ability to read, write functional requirement specifications, follow verbal instructions, interpret technical procedures, and technical writing skills beneficial.
Familiarity with validation methods (IQ/OQ/PQ).
Ability to develop cold chain packaging by performing thermal tests and execute test plans to validate shipping systems.
Strong analytical, technical, and problem-solving skills.
Ability to read, write, and comprehend English.
Good computing skills including Microsoft Office suite (Outlook, Word, Excel, PowerPoint, Project).
Works well with others and have communication and interpersonal skills.
Ability to solve practical problems both individually and in a team environment.
Works independently with minimal supervision.
Travel < 10% post-pandemic.
Preferred Knowledge, Skills, and Abilities:
- Experience using AutoCAD and/or Solidworks
- Familiarity with thermal data collection systems
- Experience in medical device design and application of test standards.
- Familiarity with rigid and flexible packaging, including rigid plastics, flexible films, resins, paperboard, corrugated, cushioning, thermoforming, and packaging equipment.
- Experience working in a hands-on environment.
- Knowledge of GMP, GAMP guidelines, ISO specifications, ASTM specifications and batch process control in the life science industry.