Sr. Research and Development Scientist

Regenity Biosciences; Oakland (NJ); Sur place; USD 110 000 - 130 000; Plein temps

Avantages offerts par ce poste

Company performance bonus eligibility

401(k) plan with company contribution

Paid time off and holidays

Medical, prescription, dental, and vis

Company paid life and AD&D insurance

Wellness Program and EAP

Tuition Reimbursement

Résumé du poste

Regenity Biosciences seeks an experienced Senior R&D Scientist to lead cross-functional teams in identifying product opportunities and defining specifications for regenerative medical devices. You will design and develop new products, ensure adherence to Design Controls, GLP/GMP and ISO standards, and coordinate prototypes with Marketing, Sales and external partners.

You will transfer products to manufacturing, train personnel, and ensure documentation and project plans are kept current.

Qualifications

• Bachelor’s degree with 6+ years of experience, Master’s 5+ years, or Ph.D. 3+ years in relevant fields.
• Experience in medical device R&D with regenerative technologies; strong knowledge of Design Control, GLP/GMP, and ISO regs.
• Solid CAD software knowledge; demonstrated technical creativity in medical device product development.
• Formal training or experience in implementing Design Controls for Medical Devices.
• Strong communication skills, multitasking in high-energy environments, and problem-solving abilities.
• Advanced Microsoft Office skills (Outlook, Word, Excel, PowerPoint).
• Experience with collagen or animal-tissue-derived materials is a plus.

Responsabilités

• Lead teams to identify product opportunities and define specifications.
• Design and develop new products for regenerative medical devices.
• Ensure programs align with Design Control procedures and regulatory requirements.
• Coordinate with Marketing, Sales, and external consultants to create prototypes and specs.
• Provide training and support for manufacturing start-up and process transfer.
• Maintain R&D equipment programs and documentation per procedures.

Connaissances

Design Controls

CAD software

Microsoft Office

Analytical skills

Problem-solving

Communication

Formation

Biomedical Science / Chemical Engineering / Materials Science / Chemistry

Outils

CAD software

Statistical analysis software

Microsoft Excel

Description du poste

Position Summary/Objectives

The Senior Research & Development Scientist will be responsible for leading teams to identify new product opportunities and define product specifications, along with designing and developing new products. This position will function as part of cross‑functional project teams working on new product development. This position ensures that company programs are executed effectively and consistently with the company’s values. The ideal candidate has a strong scientific background and can support the strategic and operational objectives of the business. The successful candidate will possess a high degree of professionalism, maturity and confidentiality.

Essential Job Functions

• Develop expertise in Collagen Matrix’s core technical competencies, including collagen, mineral, and polymer processing and surgical applications for medical devices based on the company’s regenerative technology platforms.
• Build strong relationships with key surgeons to identify customer needs and opportunities for new products
• Lead and manage efforts to perform technical feasibility assessment of new product opportunities.
• Work with outside consultants, vendors and subcontractors involved in the project to ensure protocols are adhered to and programs are kept on schedule.
• Support the transition from product development to manufacturing including technical training of personnel in order to ensure a smooth manufacturing start up.
• Oversee R&D equipment maintenance and calibration program, ensure appropriate activities are performed in accordance with established schedules.
• Write and revise R&D procedures and provide training in accordance with R&D Training program.
• Work closely with Marketing, Sales, and customers to create prototype products and develop new product specifications
• Develop and maintain effective crossfunctional working relationships and provide support to Manufacturing, Process Engineering, Regulatory and Quality Assurance
• Keep senior management and development team members informed of technical developments and issues
• Provide guidance for project team members in following Design Control procedures
• Apply risk analysis and problemsolving techniques to identify potential issues, assess their impact, and develop and implement mitigation strategies and resolution plans
• Ensure that all appropriate technical documentation, drawings, specifications are generated in compliance with Collagen Matrix’s procedures and statutory requirements (e.g., U.S. FDA and notified bodies)
• Provide technical input for analysis of manufacturing or design changes to existing products
• Effectively plan experiments and analyze data utilizing experimental design and statistical analysis software.
• Use Microsoft Office software to create reports, spreadsheets, and presentations.
• Plan and coordinate product design and development activities.
• Initiate, recommend, or provide solutions through designated channels.
• Assist with special projects and other duties as assigned

Competencies

• Meaningful Innovation
• Ownership/Accountability
• Pace/Efficiency
• Teamwork/Collaboration
• Integrity/Ethical Practice
• Resilience/Grit

Supervisory Responsibilities

This position supervises R&D Engineer Level 1 and oversees associated programs.

Education, Experience and Certification

• Bachelor’s degree with 6+ years of experience, Master’s degree with 5+ years of experience, or Ph.D. with 3+ years of experience in Biomedical Science, Chemical Engineering, Materials Science and Engineering, or Chemistry
• Experience in research and development of medical devices based upon regenerative technologies along with extensive experience with Design Control, GLP/GMP, and ISO regulations
• Solid knowledge of CAD software
• Demonstrated history of technical creativity in medical device product development
• Formal training or experience in implementation of Design Controls for Medical Devices
• Strong listening skills and the ability to communicate clearly, verbally and in writing, with people at all levels of the organization.
• Ability to prioritize and multitask in a highenergy, fastpaced environment.
• Exceptional problemsolving skills and proven track record of success
• Strong analytical skills, with the ability to analyze complex data, draw sound conclusions, and recommend practical solutions to technical problems
• Advanced skills in Microsoft Office products such as Outlook, Word, Excel, and PowerPoint or equivalent software applications.
• Previous experience in research with materials derived from collagen or other animal tissue is a plus

Other Duties as Required

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Travel

• Periodic international travel required, as well as attendance at medical device industry events throughout the U.S. and Europe.
• Must be able to travel via car and/or airplane to domestic and international sites.

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&DD insurance
• Wellness Program and Employee Assistance Program (EAP)
• Tuition Reimbursement

Salary Range: $110-$130k per year

Regenity, 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. Collagen Matrix celebrates the diversity of our team. We believe that talent, drive, and experience are the only relevant criteria for considering new team members.