Senior Sterilization Scientist

. Develop end-to-end strategies for sterile and non-sterile orthopedic medical device portfolios .

Posted 9/25/2026full-timeUnited StatesSenior💰 $92,000 - $148,350 per yearWebsite

Key responsibilities & impact

Develop end-to-end strategies for sterile and non-sterile orthopedic medical device portfolios
Develop, implement, and maintain sterilization processes
Communicate and present information on microbiology and cleanliness related to manufacturing processes and finished devices
Work with Product Development Teams to identify and mitigate microbiological quality risks and meet customer and regulatory requirements
Complete sterilization validations or product adoptions of new products
Support compliance audits, including regulatory and critical supplier audits
Conduct technical assessments of contract sterilizers, contract manufacturers, and laboratories
Perform investigations to ensure compliance with procedures and regulatory requirements
Verify that potential product quality issues are addressed
Collaborate with scientists and cross-functional teams across R&D, Packaging Engineering, Quality Engineering, Regulatory Affairs, and Marketing

What you’ll need

University/Bachelor’s or equivalent degree in Microbiology, Biomedical Science, Engineering, Food Science or related field is required
Minimum of two to four (2-4) years of related experience in the Medical Device, Pharmaceutical and/or Food Science industries
Experience in sterilization/microbiological validations
Strong partnership and communication skills to work effectively on cross-functional project teams
Experience with conducting technical assessments of in-house and external manufacturing and terminal sterilization
Proficient in Word, Excel, PowerPoint, Adobe, product lifecycle management and analytical software
Experience writing technical documents, such as standard operating procedures, protocols, and test reports is preferred
Understanding of FDA (QMSR), Canadian Medical Device Regulation (CMDR), Medical Device Regulation (MDR), ISO 13485, and ISO 14971 is strongly preferred
Understanding of EU, FDA, cGMP and cGLP regulations is preferred
Up to 10% domestic travel may be required
Fluency in oral and written English is required

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours per calendar year for employees residing in Colorado; 56 hours per calendar year for employees residing in Washington
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time – up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Inclusive interview process and accommodation support