Organogenesis · 2 weeks ago
Process Engineer I/II
Canton, MA
Full-time
Onsite
Entry, Mid Level
$86K/yr - $107K/yr
2+ years expOrganogenesis is a leading regenerative medicine company in the advanced and acute wound care space, committed to empowering healing through innovative products. The Process Engineer II role involves developing and maintaining efficient manufacturing processes for medical devices and pharmaceuticals while ensuring compliance with regulatory standards and driving continuous improvement initiatives.
BiotechnologyHealth CareManufacturingMedical
Responsibilities
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
Qualification
Required
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
Ability to read standard electrical diagrams and logic schematics
Preferred
Understanding of PLC's would be helpful but not required
Familiarity with manufacturing automation systems is helpful but not required
Benefits
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
Company
Organogenesis
Organogenesis Inc. is a regenerative medicine company.
501-1000 employees
H1B Sponsorship
Organogenesis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (1)
2022 (7)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$614.7MKey Investors
Silicon Valley BankEastward Capital Partners
2024-11-27Post Ipo Equity· $130M
2021-08-09Debt Financing· $200M
2020-12-02Post Ipo Equity· $64.7M
Leadership Team
M
Michael Catarina
Chief Technology Officer
David Francisco
Chief Financial Officer
Recent News
2026-01-09
MarketScreener
2025-12-24
Company data provided by crunchbase