Address
Form of workWorking Location: MINNESOTA, BROOKLYN PARK
Workplace Flexibility: Hybrid
Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years.
Our Purpose is to make people's lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do: Integrity - Empathy - Agility - Unity - Long-Term View
We deliver on our purpose and our core values by staying True to Life.
Job Description
This position is responsible for providing Biological Safety expertise to the Olympus Surgical Technologies America group and ensuring that the Operational activities regarding biocompatibility are in compliance with internal and external requirements and regulations. The Principal Biological Safety Engineer will be responsible for leading medical device evaluations for safety per the ISO 10993 series for new and existing products.
Job Duties
Job Qualifications
Required:
#LI-Hybrid
Why join Olympus?
Here, people matter-our health, our happiness, and our lives.
*US Only
**Limited locations
We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.
About us:
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let's realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park || Quality & Regulatory Affairs (QA/RA)
Workplace Flexibility: Hybrid
Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years.
Our Purpose is to make people's lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do: Integrity - Empathy - Agility - Unity - Long-Term View
We deliver on our purpose and our core values by staying True to Life.
Job Description
This position is responsible for providing Biological Safety expertise to the Olympus Surgical Technologies America group and ensuring that the Operational activities regarding biocompatibility are in compliance with internal and external requirements and regulations. The Principal Biological Safety Engineer will be responsible for leading medical device evaluations for safety per the ISO 10993 series for new and existing products.
Job Duties
- Responsible for the evaluation of medical devices for safety per the ISO 10993 series.
- Determine testing and evaluation strategies to assess potential Biological Safety risks for product materials.
- Partner with external laboratories for new test method development.
- Review toxicological and biocompatibility results and document in reports.
- Lead manufacturing, material, and product change evaluations for their impact on Biological Safety.
- Apply technical expertise to solve complex biocompatibility problems.
- Interface with cross functional teams during new product development
- Lead the toxicological aspect of the companies' regulatory submissions.
Job Qualifications
Required:
- Bachelor's degree in Science/Engineering/Biomedical required. MS or higher degree in biochemistry, toxicology or similar discipline preferred.
- Minimum of 10 years of experience with biocompatibility requirements within an FDA regulated medical device environment.
- Strong Knowledge of ISO 10993 and FDA's Biological Evaluation Guidance. Scientific analytical and writing skills.
- Good communication skills and writing skills.
- Familiarity with pertinent FDA, EUMDR, AAMI, OSHA and ASTM regulations and guidelines.
- Travel: <10% domestic and international
#LI-Hybrid
Why join Olympus?
Here, people matter-our health, our happiness, and our lives.
- Competitive salaries, annual bonus and 401(k)* with company match
- Comprehensive Medical, Dental, Visions coverage effective on start date
- 24/7 Employee Assistance Program
- Free virtual live and on-demand wellness classes
- Work-life balance supportive culture with hybrid and remote roles
- 12 Paid Holidays
- Educational Assistance
- Parental Leave and Adoption Assistance
- Volunteering and charitable donation match programs
- Diversity & Inclusion Programs including Colleague Affinity Networks
- On-Site Child Daycare, Café, Fitness Center**
*US Only
**Limited locations
We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.
About us:
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
Olympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let's realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park || Quality & Regulatory Affairs (QA/RA)
