Research Development Scientist/Engineer II

Regenity Biosciences; Oakland (NJ); On-site; USD 85,000 - 95,000; Full time

Benefits offered by this job

401(k) plan with company contribution

Paid time off

Medical, prescription, dental, andvis

Company‑paid life and AD&D insurance

Wellness Program

Tuition Reimbursement

Job summary

Regenity Biosciences is seeking an R&D Scientist/Engineer II to drive the design, development, and improvement of implantable regenerative medical devices from concept through commercialization.

You will apply engineering and scientific principles to support product innovation while ensuring compliance with design control and quality system requirements, working independently to support both strategic and operational objectives.

Qualifications

• Requires DHF, V&V, and design control experience.
• Experience with biomaterial characterization and data analysis.
• Familiarity with ISO 13485, 21 CFR Part 820, and ISO 14971 is preferred.

Responsibilities

• Independently contribute to implantable regenerative medical devices in compliance with design control.
• Execute and document design inputs/outputs, risk management, verification, validation, and design transfer.
• Design and conduct experiments, including feasibility studies and prototype fabrication.
• Analyze data to support product development decisions.
• Collaborate with Quality, Regulatory, Manufacturing to ensure compliance and timely project execution.

Skills

Design control

V&V

Biomaterial characterization

Data analysis

Independent work

CAD software

Education

Bachelor's degree in related field

Master's degree

Tools

CAD software

Prototyping tools

Modeling software

Job description

The Research and Development Scientist/Engineer II is responsible for the design, development, and improvement of implantable regenerative medical devices from concept through commercialization. This role applies engineering and scientific principles to support product innovation while ensuring compliance with design control and quality system requirements.

The ideal candidate combines strong technical expertise with hands‑on laboratory and product development experience and is capable of working independently to support both strategic and operational objectives.

Essential Job Functions:

• Independently contribute to the development of implantable regenerative medical devices in compliance with design control requirements.
• Execute and document design control activities, including design inputs/outputs, risk management, verification, validation, and design transfer.
• Design and conduct experiments, including feasibility studies, prototype fabrication, and characterization.
• Analyze and interpret experimental and engineering data to support product development decisions.
• Troubleshoot technical challenges across prototyping, process development, validation, and manufacturing scale‑up.
• Develop and maintain product specifications, test methods, and acceptance criteria.
• Create and execute experimental protocols, technical reports, and documentation to support verification, validation, and regulatory submissions.
• Collaborate with Quality, Regulatory, Manufacturing, and external partners to ensure compliance and timely project execution.
• Support R&D equipment calibration and maintenance programs in accordance with quality system requirements.
• Develop and revise SOPs, work instructions, and technical documentation.
• Maintain accurate and compliant design history file (DHF) documentation, including lab notebooks, protocols, and reports.
• Ensure laboratory operations meet safety, organization, and inspection-readiness standards. Train and support R&D personnel on procedures, equipment, and test methods.
• Contribute to continuous improvement initiatives through established quality and change control processes.
• Participate in cross‑functional and special projects as needed.

Core Values

• 1. Innovation and Scientific Curiosity
• 2. Ownership and Accountability
• 3. Execution and Efficiency
• 4. Collaboration and Teamwork
• 5. Integrity and Ethical Practice
• 6. Resilience and adaptability

Education, Experience and Certification:

• -Requires 2–5 years of medical device R&D experience with a Bachelor's, or
• -1–3 years of related experience with a Master's Degree
• -Requires design control/DHF, V&V, and biomaterial characterization
• -Prefers Collagen-based or other implantable biomaterials experience, plus familiarity with ISO 13485, 21 CFR Part 820, and ISO 14971 -V&V and DHF responsibilities and hands‑on biomaterial characterization
• -Experience with experimental design, material characterization, data analysis, and laboratory techniques.
• -Ability to work independently with minimal supervision while managing multiple priorities.
• -Strong analytical and problem‑solving skills with a data‑driven approach.
• -Effective collaborator with cross‑functional teams.
• -Strong written and verbal communication skills, including technical documentation
• -Experience with CAD software, prototyping tools or model software is a plus. Ability to work independently with minimal supervision while managing multiple priorities.
• -Strong analytical and problem‑solving skills with a data‑driven approach.
• -Effective collaborator with cross‑functional teams.

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Rewards Package:

• Company performance bonus eligibility
• 401(k) plan with company contribution
• Paid time off and paid holidays
• Medical, prescription, dental, and vision insurance
• Company‑paid life and AD&D insurance
• Wellness Program and Employee Assistance Program (EAP)
• Tuition Reimbursement

Salary Range: $85,000-$95,000 per year

Regenity Biosciences, Inc. is an Equal Opportunity Employer. We consider applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation or any other legally protected status. Regenity Biosciences celebrates the diversity of our team. We believe that talent, drive, and experience are the only relevant criteria for considering new team members.