About this opportunity
Regenity Biosciences lists this Research Development Scientist/Engineer II opportunity in oakland, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Position Summary/ Objectives
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 scaleup.
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 inspectionreadiness 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 crossfunctional and special projects as needed.
Competencies
Innovation and Scientific Curiosity
Ownership and Accountability
Execution and Efficiency
Collaboration and Teamwork
Integrity and Ethical Practice
Resilience and adaptability
Education, Experience and Certification
Bachelor’s or Master’s degree in Biomedical Engineering, Biological Sciences, Material Science or related field required.
Minimum of 3 years of experience with a Bachelor’s degree, or minimum of 2 years with a Master’s degree, in medical device R&D, preferably in regenerative or implantable technologies.
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 problemsolving skills with a datadriven approach.
Effective collaborator with crossfunctional 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 problemsolving skills with a datadriven approach.
Effective collaborator with crossfunctional teams.
Strong written and verbal communication skills, including technical documentation.
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.
Total Rewards & Benefits
Regenity offers a comprehensive rewards package, including:
Company performance bonus eligibility
401(k) plan with company contribution
Paid time off and paid holidays
Medical, prescription, dental, and vision insurance
Companypaid 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.
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Worksite address
oakland, NJ, 07436, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.