Remote candidates may be considered for exceptional qualifications and must reside in AZ, FL, GA ... Collaborate with Biocompatibility, Manufacturing, Research & Development (R&D), and New Product ...
Remote candidates may be considered for exceptional qualifications and must reside in AZ, FL, GA ... Collaborate with Biocompatibility, Manufacturing, Research & Development (R&D), and New Product ...
Biocompatibility Remote information
What is a biocompatibility remote job?
Biocompatibility Remote jobs involve assessing and ensuring that medical devices, materials, or products are safe and compatible with biological systems while working from a remote location. Professionals in these roles typically conduct risk assessments, review scientific literature, and prepare regulatory documentation to support biocompatibility claims. They collaborate with cross-functional teams, interpret regulatory standards such as ISO 10993, and help guide product development to meet safety requirements. Remote biocompatibility specialists leverage digital tools to communicate and manage projects effectively from outside a traditional office setting.
What skills and qualifications are needed to thrive as a biocompatibility specialist working remotely?
To thrive as a Biocompatibility Specialist, you need a solid background in biological sciences, toxicology, or biomedical engineering, often supported by a relevant degree and experience with medical device regulations. Familiarity with ISO 10993 standards, risk assessment tools, and regulatory submission systems is typically required. Strong analytical thinking, attention to detail, and effective written communication are essential soft skills, especially in a remote environment. These competencies ensure accurate safety evaluations and successful regulatory approvals for medical devices, even when collaborating virtually.
What are common challenges faced by remote biocompatibility professionals, and how can they be managed?
Remote biocompatibility professionals often encounter challenges related to cross-functional communication and access to laboratory data, as much of the work involves collaborating with regulatory, R&D, and laboratory teams. To manage these challenges, it is important to establish clear communication channels, schedule regular virtual meetings, and utilize collaborative project management tools. Staying organized and proactively reaching out to on-site team members for data clarification can also help ensure projects remain on track and meet regulatory deadlines.
What is the difference between Biocompatibility Remote vs Biocompatibility Specialist?
| Aspect | Biocompatibility Remote | Biocompatibility Specialist |
|---|---|---|
| Credentials | Typically requires knowledge of biocompatibility testing, certifications vary | Requires certifications like ISO 10993, relevant degrees, and experience |
| Work Environment | Primarily remote, involving documentation, research, and communication | Often lab-based or on-site testing, but may include remote report review |
| Employer & Industry Usage | Used by medical device companies, contract labs, and regulatory consultants | Employed by medical device manufacturers, testing labs, and regulatory agencies |
While both roles focus on biocompatibility, Biocompatibility Remote typically involves remote research, documentation, and compliance tasks, whereas a Biocompatibility Specialist often conducts hands-on testing and lab work. The remote role offers flexibility, while the specialist role emphasizes direct testing expertise.
What are the most commonly searched types of Biocompatibility jobs in Pennsylvania?
The most popular types of Biocompatibility jobs in Pennsylvania are:
What are popular job titles related to Biocompatibility Remote jobs in Pennsylvania?
For Biocompatibility Remote jobs in Pennsylvania, the most frequently searched job titles are:
What job categories do people searching Biocompatibility Remote jobs in Pennsylvania look for?
The top searched job categories for Biocompatibility Remote jobs in Pennsylvania are:
Material Science Engineer - Biocompatibility ISO 10993
Harleysville, PA • On-site, Remote
Full-time
Re-posted 14 days ago
Job description
Material Science Engineer
Location: Preference will be given to candidates located within a reasonable commuting distance of Harleysville, PA for on-site work.
Remote candidates may be considered for exceptional qualifications and must reside in AZ, FL, GA, NJ, NC, TN, or TX.
Please note: This position is not eligible for relocation assistance or employment sponsorship now or in the future.Position Summary
We are seeking a Materials Engineer to provide technical expertise in material selection and qualification for the design and development of disposable medical devices-from concept through commercialization. This role collaborates closely with cross-functional engineering teams and ensures adherence to Design Control standards, quality systems, and regulatory requirements.
The ideal candidate will bring strong experience in material characterization, material science, medical device manufacturing, ISO 10993, EU MDR, FDA Guidance regulatory compliance and leadership/mentorship within engineering teams.Key Responsibilities
We are committed to creating a diverse and inclusive workplace. We provide equal employment opportunities to all employees and applicants regardless of race, color, religion, gender, age, disability, or veteran status.
Location: Preference will be given to candidates located within a reasonable commuting distance of Harleysville, PA for on-site work.
Remote candidates may be considered for exceptional qualifications and must reside in AZ, FL, GA, NJ, NC, TN, or TX.
Please note: This position is not eligible for relocation assistance or employment sponsorship now or in the future.Position Summary
We are seeking a Materials Engineer to provide technical expertise in material selection and qualification for the design and development of disposable medical devices-from concept through commercialization. This role collaborates closely with cross-functional engineering teams and ensures adherence to Design Control standards, quality systems, and regulatory requirements.
The ideal candidate will bring strong experience in material characterization, material science, medical device manufacturing, ISO 10993, EU MDR, FDA Guidance regulatory compliance and leadership/mentorship within engineering teams.Key Responsibilities
- Lead material selection and qualification processes for product design and development.
- Evaluate material changes and define/execute required validation and testing.
- Review product designs for material manufacturability, performance, and cost efficiency.
- Ensure proper review and release of materials, drawings, and documentation.
- Assess material properties and compatibility for intended product use.
- Collaborate with suppliers to define material processing and support production needs.
- Collaborate with Biocompatibility, Manufacturing, Research & Development (R&D), and New Product Development (NPD) teams to support material science, chemical characterization, and product safety activities for FDA, EU MDR, and global regulatory submissions, technical documentation, and regulatory responses.
- Evaluate material composition, additives, impurities, processing aids, degradation products, and residual chemicals.
- Assess material, supplier, formulation, manufacturing, sterilization, and packaging changes, determine requires testing, validation, risk assessment, and regulatory documentation for proposed changes.
- Prepare responses to FDA, notified body, and other regulatory deficiencies related to materials and biocompatibility.
- Interpret and review complex chemical data sets from outside analytical and biological laboratories and compare results to supplier documentation.
- Evaluate scientific evidence and develop defensible conclusions using a weight-of-evidence approach.
- Maintain material and material property databases.
- Support manufacturing operations and resolve production issues.
- Travel to other facilities as needed (5-15%).
- Bachelor's degree in Materials Science, Polymer Science, Chemistry or related technical field.
- 3-5 years of experience in manufacturing or medical device industry.
- Strong experience in material characterization and selection in accordance with ISO 14971, ISO 10993 Series of Standards, EU MDR, and FDA Guidance.
- Experience in engineering design, validation, and product testing environments
- Knowledge of ISO 10993, ISO 14971 is required.
- Familiarity with FDA, GMP, GLP, and EU MDR regulations.
- Experience with CAD software (SolidWorks preferred).
- Knowledge of injection molding, extrusion, and secondary operations.
- Understanding of GD&T and engineering drawings.
- Experience with validation testing methods and statistical analysis.
- Familiarity with FEA and mold flow analysis.
- Strong problem-solving and analytical abilities.
- Excellent written and verbal communication skills.
- Ability to lead projects and mentor team members.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project, Outlook).
- Problem solving and analytical thinking.
- Technical expertise and continuous learning mindset.
- Collaboration and teamwork.
- Communication (written and verbal).
- Quality focus and attention to detail.
- Leadership and mentoring.
- Adaptability and initiative.
- Sound judgment and decision-making.
- Ability to sit, stand, walk, and use hands regularly.
- Occasional lifting up to 25 lbs.
- Ability to work in manufacturing, lab, and prototype environments.
- Vision abilities including close and distance vision, color vision, and depth perception.
- Combination of office, manufacturing floor, engineering lab, and prototype shop environments.
- Exposure to mechanical equipment and moderate noise levels.
- Travel required: 5-15%.
- Must have or be able to obtain a valid passport.
We are committed to creating a diverse and inclusive workplace. We provide equal employment opportunities to all employees and applicants regardless of race, color, religion, gender, age, disability, or veteran status.
About Medical Components
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
51 - 200 Employees
Headquarters location
Harleysville, PA, US
Year founded
1978