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Biocompatibility Manager Jobs in California (NOW HIRING)

Intuitive

Senior Manager, Instruments

Sunnyvale, CA · On-site

Manage, coach, and mentor engineers, technicians, and drafters as required * Ensure design ... Expertise in biocompatibility principles and regulatory requirements, e.g. ISO 10993 * Knowledge of ...

black.ai

Senior Mechanical Engineer

San Francisco, CA · On-site

$120 - $150/hr

Manage external partners (CMs, suppliers, test labs) to ensure design intent and timelines are met ... Experience with implantable materials, hermetic or semi‑hermetic packaging, and biocompatibility ...

Capstan Medical, Inc.

Quality Engineer

Santa Cruz, CA · On-site

$83K - $107K/yr

Collaborate with R&D and Regulatory Affairs teams to ensure that biocompatibility requirements are ... Strong understanding of quality management systems. * Excellent problem-solving skills and ability ...

Capstan Medical, Inc.

Quality Engineer

Santa Cruz, CA

$83K - $107K/yr

Collaborate with R&D and Regulatory Affairs teams to ensure that biocompatibility requirements are ... Strong understanding of quality management systems. * Excellent problem-solving skills and ability ...

Capstan Medical, Inc.

Quality Engineer

Santa Cruz, CA · On-site

$83K - $107K/yr

Collaborate with R&D and Regulatory Affairs teams to ensure that biocompatibility requirements are ... Strong understanding of quality management systems. * Excellent problem-solving skills and ability ...

SaniSure LLC

Supplier Quality Engineer

Camarillo, CA · On-site

$95K - $105K/yr

Ensure compliance with biocompatibility, material, and regulatory requirements. * Support regulatory submissions requiring supplier documentation. Risk Management * Participate in supplier risk ...

Cala Health

Senior Mechanical Design Engineer

San Mateo, CA · On-site

$102K - $141K/yr

Lead mechanical design and reviews, managing complex schedules and technical requirements ... biocompatibility). * Quality & Rigor: Demonstrated experience with medical device phase-gate ...

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Biocompatibility Manager information

What are the key skills and qualifications needed to thrive as a biocompatibility manager?

To thrive as a Biocompatibility Manager, you need expertise in toxicology, materials science, and regulatory standards, typically supported by a degree in a life science field and experience with medical device biocompatibility testing. Familiarity with ISO 10993 standards, risk assessment tools, and regulatory submission systems is essential. Strong analytical thinking, attention to detail, and effective communication skills help in collaborating with cross-functional teams and ensuring regulatory compliance. These skills and qualities are vital for ensuring product safety, regulatory approval, and successful market entry for medical devices.

What are the common challenges a biocompatibility manager faces when coordinating cross-functional teams during product development?

A Biocompatibility Manager often encounters challenges in aligning the priorities and timelines of various teams such as R&D, regulatory affairs, and quality assurance. Ensuring clear communication about testing requirements and regulatory updates is vital, as misunderstandings can lead to delays or non-compliance issues. Additionally, the manager must balance thorough risk assessments with project deadlines, all while staying current with evolving international standards. Effective collaboration and proactive problem-solving are key to overcoming these challenges and ensuring the safety and compliance of medical devices.

What does a biocompatibility manager do?

A Biocompatibility Manager oversees the evaluation and testing of medical devices and materials to ensure they are safe and compatible with human tissues. Their responsibilities include designing testing protocols, interpreting regulatory requirements, and ensuring compliance with international standards like ISO 10993. They work closely with research, development, and regulatory teams to address any risks related to biological safety. Their work is critical for gaining regulatory approvals and ensuring patient safety.

What is the difference between Biocompatibility Manager vs Biocompatibility Specialist?

AspectBiocompatibility ManagerBiocompatibility Specialist
CredentialsTypically requires a degree in life sciences or biomedical engineering; certifications like ISO 10993 are commonSimilar educational background; often holds certifications in biocompatibility testing
Work EnvironmentOversees teams, manages projects, and ensures compliance across departmentsPerforms testing, data analysis, and reports within labs or R&D settings
Industry UsageUsed in regulatory, quality assurance, and management roles within medical device companiesPrimarily involved in testing and technical analysis within laboratories

The main difference is that the Biocompatibility Manager oversees testing programs and compliance strategies, while the Biocompatibility Specialist focuses on conducting tests and technical analysis. Both roles require similar credentials but differ in scope and responsibilities.

What are the most commonly searched types of Biocompatibility jobs in California?

The most popular types of Biocompatibility jobs in California are:

What are popular job titles related to Biocompatibility Manager jobs in California?

For Biocompatibility Manager jobs in California, the most frequently searched job titles are:

What job categories do people searching Biocompatibility Manager jobs in California look for?

The top searched job categories for Biocompatibility Manager jobs in California are:

What cities in California are hiring for Biocompatibility Manager jobs?

Cities in California with the most Biocompatibility Manager job openings:

Biocompatibility Manager jobs near you
Infographic showing various Biocompatibility Manager job openings in California as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

Microbiology Services Assistant Manager

Pacific BioLabs

Hercules, CA • On-site

Full-time

Medical, Dental, Vision, Life, Retirement

Re-posted 8 days ago

Job description

Job Type
Full-time
Description
Pacific BioLabs is an independent CRO providing cGMP/GLP testing in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. We are currently hiring to support our clients in the pharmaceutical, biotech, and medical device fields. Join us in our mission to improve public health through science!
PBL has an immediate opening for a Microbiology Services Assistant Manager. This is a full-time, onsite, exempt position reporting to the Microbiology Services Manager. The Assistant Manager supports laboratory operations, quality systems, staff development, and client service activities in a regulated cGMP/GLP environment. This role combines hands-on technical expertise with leadership responsibilities and offers opportunities for professional growth and advancement within the department. The position supervises Microbiology Analysts and Technicians and assists with staff development, performance management, and operational planning.
RESPONSIBILITIES FOR THE MICROBIOLOGY SERVICES ASSISTANT MANAGER INCLUDE BUT ARE NOT LIMITED TO:
SERVICE RESPONSIBILITIES TO CLIENTS
  • Develop, implement, and maintain processes that ensure exceptional client service, timely study execution, and compliance with established quality and turnaround-time standards.
  • Partner with clients and internal stakeholders to support specialized study development, scheduling, execution, reporting, and resolution of technical or service-related issues.
  • Ensure client concerns and complaints are addressed promptly and in accordance with applicable Pacific BioLabs SOPs.
  • Lead departmental and cross-functional initiatives to enhance client satisfaction, operational efficiency, and service quality.

SERVICE RESPONSIBILITIES TO INTERNAL CUSTOMERS
  • Collaborate with the Microbiology Services Manager and other departments to ensure studies are conducted efficiently, accurately, and in compliance with applicable quality and regulatory requirements.
  • Ensure microbiology staff have the personnel, equipment, training, and resources necessary to successfully complete testing activities within a cGMP/GLP-regulated environment.
  • Coordinate with Quality Assurance, Administrative Services, and other functional groups to address regulatory, reporting, billing, and operational matters.
  • Foster a collaborative, team-oriented culture and lead initiatives that improve departmental effectiveness and overall laboratory performance.

TECHNICAL RESPONSIBILITIES
  • Serve as a subject matter expert on microbiological testing standards, including USP, European Pharmacopoeia, and AAMI requirements relevant to pharmaceutical and medical device testing.
  • Maintain expertise in applicable cGMP, GLP, and laboratory quality system requirements.
  • Oversee and support routine and specialized microbiology studies, including study scheduling, preparation, execution, data review, and report approval.
  • Lead the development, review, implementation, and continuous improvement of department SOPs, test methods, and study protocols.

ADMINISTRATIVE RESPONSIBILITIES
  • Comply with Pacific BioLabs policies, SOPs, and regulatory requirements related to documentation, reporting, training, and client communications.
  • Participate in and support ongoing training, compliance, and quality improvement initiatives.

LEADERSHIP RESPONSIBILITIES
  • Communicate departmental priorities, organizational objectives, and performance expectations to microbiology staff.
  • Ensure that client service is given top priority by all microbiology staff.
  • Coordinate and direct departmental activities related to testing, training, study execution, data review, and reporting.
  • Establish departmental and individual performance goals and monitor progress toward completion.
  • Monitor departmental performance and communicate significant operational, staffing, or quality concerns to the Microbiology Manager.
  • Oversee onboarding, training, and development activities for microbiology staff.
  • Support laboratory equipment maintenance, calibration, and operational readiness activities.
  • Conduct annual performance evaluations of all department staff.

Requirements
EDUCATION/EXPERIENCE
  • Bachelor's degree or higher in Microbiology, Biological Sciences, or a related discipline required.
  • Advanced knowledge of current guidelines for microbiological and sterility assurance testing of medical devices and pharmaceuticals required. Must be well-versed in both USP and European test methods, as well as AAMI guidelines.
  • Minimum of 4 years of microbiology laboratory experience in the pharmaceutical, medical device, CRO, biotechnology, or related life sciences industry required.
  • Prior leadership, supervisory, project management, or team lead experience strongly preferred.

TECHNICAL SKILLS
General Skills/Scientific Aptitude:
  • Advanced math and computer skills required.
  • Solid grasp of advanced scientific language and current industry standards and practices required.
  • Critical thinking skills appropriate for advanced problem-solving activities required.
  • Intellectual aptitude for analyzing data and drawing conclusions based on current guidelines, SOPs, etc.

Specific Laboratory Skills:
  • Must be proficient at all of the laboratory skills required of Microbiology Analysts in the department. This includes aseptic technique, serial dilutions, gram staining procedures, and preparation of test media. This also includes microorganism culturing techniques and basic biochemical characteristic evaluation, as well as operation of sterilization equipment. The Assistant Manager should also be proficient at bioburden recovery, radiation dose setting, and cleaning-disinfection validation procedures.

INTERPERSONAL SKILLS
  • Excellent language and communication skills required. Must be able to clearly communicate priorities and responsibilities on a daily basis.
  • Solid leadership skills required. Must be able to give directions clearly. Must be able to build consensus, effectively manage priorities, and unite diverse individuals in pursuit of common goals.
  • Must be capable of working with persons from diverse backgrounds.

PHYSICAL ABILITIES
  • Requires frequent use of hands, arms, and manual dexterity to perform laboratory procedures and operate laboratory equipment.
  • Must be able to wear required personal protective equipment (PPE).
  • Must be able to occasionally lift and move materials weighing up to 25 pounds.
  • Must be capable of working at lab bench for up to three hours at a time, and for up to eight hours on a given day.
  • Must be capable of working at a desk and computer terminal for up to three hours at a time, and for up to eight hours on a given day.

The pay range for this position is $95,000 to $125,000 annually. The base pay offered will take into account internal equity and also may vary depending on the candidate's job-related knowledge, skills, and experience among other factors. This position will be eligible for medical, dental, vision, life insurance, 401k, and other benefits.
PBL is an equal opportunity employer committed to diversity and inclusion. PBL considers all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veterans' status, or any other legally protected factors.

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