Biocompatibility Scientist
Location
Massachusetts + 1 moreAll locations: Massachusetts | Pennsylvania
Posted
2 days ago
Salary
$76K - $121.9K / year
Seniority
Mid Level
Job Description
Biocompatibility Scientist
OneTrust
• Evaluates DePuy Synthes medical device products and materials for biological safety per international medical device regulations and standards, GLP (Good Laboratory Practice) guidelines and internal procedures. • Designs, initiates, coordinates, and interprets laboratory investigations for biocompatibility and toxicology studies for MD materials and products. • Applies technical expertise to solve biocompatibility problems related to the ISO 10993 standards and regulatory authority requirements for product safety. • Liaises with internal and cross-functional team members to review existing product documentation and coordinates, together with more senior staff, biocompatibility test strategies to ensure appropriate planning and execution of required testing and completion of relevant deliverables. • Reviews, interprets, and summarizes testing data and ensures appropriate documentation and coordination of central documentation procedures required for risk assessment report completion. • Interacts closely with and provides technical guidance and expertise to internal stakeholders (e.g., R&D, Clinical Affairs, Regulatory Affairs, Manufacturing, Quality Engineering, and Supplier Management). • Can support regulatory/notified body requests as part of Audits and File/Product submissions/Reviews in applicable markets. • Maintains effective communication of business-related issues or opportunities to next management level and if necessary, SMEs, via proper communication methods and/or tools. • Identifies and evaluates potential risks and drives resolution with team members, peers, PMO and management. • Participates in continuous improvement activities and actively participates in shaping processes and procedures. • Responsible for communicating business related issues or opportunities to next management level. • Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. • For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable. • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. • Performs other duties assigned as needed.
Job Requirements
- Bachelor’s or master’s degree in biology, chemistry, toxicology, microbiology, biomedical engineering, or a related scientific discipline with a minimum of 2 years of industrial experience in biocompatibility evaluation, or PhD with at least 1 year of industrial experience in biocompatibility evaluation.
- A minimum 1-2 years of experience in biocompatibility assessment and evaluation in a medical device, pharmaceutical, and/or consumer product company or similar combination of professional training and multi-year experience in the industry.
- Experience working in a regulated environment of medical device safety and supporting product submission and audit is required; support for worldwide market registration is preferred.
- Knowledge of toxicology & biocompatibility assessment of medical devices, coordination, and interpretation of biocompatibility and chemistry studies per relevant guidelines and requirements.
- Understanding of manufacturing processes of medical devices is preferred.
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- 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
- 10 days Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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