Scottsdale, AZ · On-site
$105K - $144K/yr
... management. • Comply with company policies and procedures. • Maintain project schedule and ... biocompatibility requirements. • Develop and maintain relationships with key opinion leaders and ...
Scottsdale, AZ · On-site
$105K - $144K/yr
... management. • Comply with company policies and procedures. • Maintain project schedule and ... biocompatibility requirements. • Develop and maintain relationships with key opinion leaders and ...
This position plays a critical part in the biocompatibility and analytical testing pipeline for ... Study Coordination & Timeline Management * Support laboratory analysts by ensuring samples are ...
This position plays a critical part in the biocompatibility and analytical testing pipeline for ... Study Coordination & Timeline Management * Support laboratory analysts by ensuring samples are ...
Scottsdale, AZ · On-site
$105K - $144K/yr
... management. · Comply with company policies and procedures. · Focus on delivering products to ... biocompatibility requirements. · Develop and maintain relationships with key opinion leaders and ...
Scottsdale, AZ · On-site
$105K - $144K/yr
... management. · Comply with company policies and procedures. · Focus on delivering products to ... biocompatibility requirements. · Develop and maintain relationships with key opinion leaders and ...
This role requires deep expertise in medical device development, regulatory pathways, operations, sterilization, biocompatibility, and cross-functional project management. The Senior Project Manager ...
This role requires deep expertise in medical device development, regulatory pathways, operations, sterilization, biocompatibility, and cross-functional project management. The Senior Project Manager ...
Scottsdale, AZ · On-site
$101K - $139K/yr
... management. · Comply with company policies and procedures. · Focus on delivering products to ... biocompatibility requirements. · Develop and maintain relationships with key opinion leaders and ...
Quick apply
Scottsdale, AZ · On-site
$101K - $139K/yr
... management. · Comply with company policies and procedures. · Focus on delivering products to ... biocompatibility requirements. · Develop and maintain relationships with key opinion leaders and ...
OR · On-site +1
$150K - $200K/yr
Manage team responsible for medical device biocompatibility support * Responsible for project strategies, risk assessments, biocompatibility evaluation plans and reports for medical devices * Ensures ...
OR · On-site +1
$150K - $200K/yr
Manage team responsible for medical device biocompatibility support * Responsible for project strategies, risk assessments, biocompatibility evaluation plans and reports for medical devices * Ensures ...
This role requires deep expertise in medical device development, regulatory pathways, operations, sterilization, biocompatibility, and cross-functional project management. The Senior Project Manager ...
This role requires deep expertise in medical device development, regulatory pathways, operations, sterilization, biocompatibility, and cross-functional project management. The Senior Project Manager ...
Coordinates the biocompatibility testing of new products and materials. Ensure compliance to Good ... Manages EO Sterilization Validations, Out of Tolerance Investigations, Bacterial Endotoxin Testing.
Coordinates the biocompatibility testing of new products and materials. Ensure compliance to Good ... Manages EO Sterilization Validations, Out of Tolerance Investigations, Bacterial Endotoxin Testing.
OR · On-site +1
$150K - $200K/yr
Manage team responsible for medical device biocompatibility support * Responsible for project strategies, risk assessments, biocompatibility evaluation plans and reports for medical devices * Ensures ...
OR · On-site +1
$150K - $200K/yr
Manage team responsible for medical device biocompatibility support * Responsible for project strategies, risk assessments, biocompatibility evaluation plans and reports for medical devices * Ensures ...
Scottsdale, AZ · On-site
$101K - $139K/yr
... management. • Comply with company policies and procedures. • Maintain project schedule and ... biocompatibility requirements. • Develop and maintain relationships with key opinion leaders and ...
Scottsdale, AZ · On-site
$101K - $139K/yr
... management. • Comply with company policies and procedures. • Maintain project schedule and ... biocompatibility requirements. • Develop and maintain relationships with key opinion leaders and ...
Scottsdale, AZ · On-site
$101K - $139K/yr
... senior management. • Comply with company policies and procedures. • Focus on delivering ... biocompatibility requirements. • Develop and maintain relationships with key opinion leaders and ...
Scottsdale, AZ · On-site
$101K - $139K/yr
... senior management. • Comply with company policies and procedures. • Focus on delivering ... biocompatibility requirements. • Develop and maintain relationships with key opinion leaders and ...
$140K - $170K/yr
Oversee Microbiological/Biocompatibility efforts in support of NPD/Sustaining Engineering efforts ... Strong project management skills with the ability to prioritize for maximum results (multi-task ...
Quick apply
$140K - $170K/yr
Oversee Microbiological/Biocompatibility efforts in support of NPD/Sustaining Engineering efforts ... Strong project management skills with the ability to prioritize for maximum results (multi-task ...
San Diego, CA · On-site
$140 - $160/hr
The successful candidate will drive mechanical architecture decisions from concept through verification, balancing biocompatibility, manufacturability, thermal management, and regulatory requirements ...
San Diego, CA · On-site
$140 - $160/hr
The successful candidate will drive mechanical architecture decisions from concept through verification, balancing biocompatibility, manufacturability, thermal management, and regulatory requirements ...
Handson experience with biocompatibility testing, surface characterization, or failure analysis. * Familiarity with supplier qualification and materials change management. * Experience mentoring or ...
Handson experience with biocompatibility testing, surface characterization, or failure analysis. * Familiarity with supplier qualification and materials change management. * Experience mentoring or ...
Hands-on experience with biocompatibility testing, surface characterization, or failure analysis. * Familiarity with supplier qualification and materials change management. * Experience mentoring or ...
Hands-on experience with biocompatibility testing, surface characterization, or failure analysis. * Familiarity with supplier qualification and materials change management. * Experience mentoring or ...
Minneapolis, MN · On-site
$115K - $140K/yr
Strong Device Design Control and Risk Management * Biocompatibility research and testing experience is ideal * Understanding and experience with Design Control and V&V
Quick apply
Minneapolis, MN · On-site
$115K - $140K/yr
Strong Device Design Control and Risk Management * Biocompatibility research and testing experience is ideal * Understanding and experience with Design Control and V&V
San Diego, CA · On-site
$140K - $160K/yr
The successful candidate will drive mechanical architecture decisions from concept through verification, balancing biocompatibility, manufacturability, thermal management, and regulatory requirements ...
Quick apply
San Diego, CA · On-site
$140K - $160K/yr
The successful candidate will drive mechanical architecture decisions from concept through verification, balancing biocompatibility, manufacturability, thermal management, and regulatory requirements ...
Handson experience with biocompatibility testing, surface characterization, or failure analysis. * Familiarity with supplier qualification and materials change management. * Experience mentoring or ...
Handson experience with biocompatibility testing, surface characterization, or failure analysis. * Familiarity with supplier qualification and materials change management. * Experience mentoring or ...
Systems Engineering to ISO 14971 risk management and design controls; Chemical/Materials Engineering to material selection, substance compliance (REACH, RoHS), and biocompatibility testing; Computer ...
Systems Engineering to ISO 14971 risk management and design controls; Chemical/Materials Engineering to material selection, substance compliance (REACH, RoHS), and biocompatibility testing; Computer ...
Mountain View, CA · Hybrid
$180K - $200K/yr
Strong understanding of ISO 13485, FDA 21 CFR Part 820 & Part 11, EU MDR, ISO 14971 (Risk Management), ISO 10993-1 Biocompatibility, FDA/EU/UK Food Safe Regulations, WERCSmart, RoHS compliance.
Mountain View, CA · Hybrid
$180K - $200K/yr
Strong understanding of ISO 13485, FDA 21 CFR Part 820 & Part 11, EU MDR, ISO 14971 (Risk Management), ISO 10993-1 Biocompatibility, FDA/EU/UK Food Safe Regulations, WERCSmart, RoHS compliance.
| Aspect | Biocompatibility Manager | Biocompatibility Specialist |
|---|---|---|
| Credentials | Typically requires a degree in life sciences or biomedical engineering; certifications like ISO 10993 are common | Similar educational background; often holds certifications in biocompatibility testing |
| Work Environment | Oversees teams, manages projects, and ensures compliance across departments | Performs testing, data analysis, and reports within labs or R&D settings |
| Industry Usage | Used in regulatory, quality assurance, and management roles within medical device companies | Primarily 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.
$105K - $144K/yr
Full-time
Posted 6 days ago
The Senior R&D Engineer role is responsible for designing, developing, validating, and implementing various methods and processes, leading and assisting in projects to introduce new products into production. This role is expected to bring unique perspectives and creative solutions to challenges faced during reverse engineering and reprocessing technique development.
Essential Duties and Responsibilities:
• Assist and/or lead in development of new medical device platforms complying with design control process including applicable FDA and ISO requirements.
• Develop, write, and execute test methods.
• Train manufacturing/QC personnel as needed on test methods or manufacturing processes.
• Generate formal test protocols and reports.
• Execute test protocols and conduct bench testing. Document test results per GDP, ISO, and FDA requirements.
• Coordinate and oversee test sample builds. Assist with test sample builds as required.
• Use Solidworks to design test fixtures and devices. (if applicable)
• Design and fabricate test fixtures, tooling and equipment. (if applicable)
• Work with purchasing department to specify and procure capital equipment.
• Serve as a cross-functional team member for various project-related activities.
• Assist or lead process improvement projects to reduce costs.
• Assist with DFMEA and PFMEA risk assessments.
• Compile project status updates and present to senior management.
• Comply with company policies and procedures.
• Maintain project schedule and deliver projects on time.
• Focus on delivering products to support the R&D project pipeline.
• Provide technical leadership to junior engineers and technicians.
Clinical Support Responsibilities:
• Attend clinical cases for learning, device launch, and troubleshooting.
• Interact with clinicians and field personnel to understand clinical needs and provide technical support.
• Develop and maintain a deep understanding of medical device reprocessing techniques, including cleaning, sterilization, and biocompatibility requirements.
• Develop and maintain relationships with key opinion leaders and clinical partners.
Medical Device Reprocessing Responsibilities:
• Develop and optimize reprocessing methods for single-use medical devices.
• Conduct performance, biocompatibility and sterilization testing on reprocessed devices.
• Ensure compliance with all regulatory requirements for medical device reprocessing.
• Participate in cross-functional teams to introduce reprocessed devices into production.
Supervisory Responsibilities:
· Provide mentoring and guidance to other R&D team members, as well as supervise and manage the work of junior engineers.
Education, Qualifications and Skills:
· Minimum education: Bachelor's degree in engineering discipline (or equivalent experience)
· Minimum experience: 7-12 years of experience
· Strong background in R&D with experience in electromechanical medical devices.
· Experience with various types of medical device design verification testing in accordance with FDA regulations: device functional performance, biocompatibility, sterilization, packaging, transportation simulation, real-time and accelerated aging, etc.
· Excellent technical writing skills and substantial experience writing test plans, protocols, and reports.
· Excellent problem-solving skills as well as keen analytical abilities.
· Knowledge of Design Controls, Risk Management, Statistics, Engineering Principles, Test Method Development, Test Method Validation (Gage R&R), and Design Verification / Validation.
· Proficiency in CAD design and drafting (SolidWorks) a plus.
· Ability to work in a fast-paced, collaborative team environment.
· Strong hands-on prototyping skills.
· Self-starter and highly motivated.
· Ability to have fun by motivating and encouraging other team members.
