Regenerative Medicine Product Development Engineer – Cambridge, MA

Are you an engineer with a passion for innovation in healthcare? We are looking for a Regenerative Medicine Product Development Engineer to join our team in Cambridge, MA. This is an exciting opportunity to be part of a cutting-edge company at the forefront of regenerative medicine, working on groundbreaking therapies and technologies. If you’re driven by scientific discovery and eager to contribute to transforming the future of medicine, this is your chance to make a significant impact.

Shape the Future of Regenerative Medicine

Our company, a leader in regenerative medicine, is seeking a Product Development Engineer to lead the development of next-generation treatments. Located in Cambridge, MA, this role offers the opportunity to work on innovative solutions that have the potential to change the landscape of healthcare. The ideal candidate will bring a deep understanding of biomedical engineering, experience in product development, and a commitment to improving patient outcomes. If you have the expertise and passion to drive transformative medical solutions, this is the role for you.

Key Responsibilities of the Regenerative Medicine Product Development Engineer

Product Development & Innovation: Lead the design, development, and enhancement of regenerative medicine products, utilizing cutting-edge technologies to advance the field. Collaborate with cross-functional teams to ensure that products meet regulatory standards, clinical requirements, and patient needs.

Technical Expertise & Problem Solving: Apply engineering principles to solve complex challenges in the development of regenerative therapies. Contribute to the optimization of manufacturing processes, ensuring efficiency, scalability, and adherence to quality standards.

Regulatory & Compliance: Ensure that all product development activities comply with FDA regulations, Good Manufacturing Practices (GMP), and other relevant industry standards. Work closely with regulatory teams to prepare documentation and support regulatory submissions.

Cross-Functional Collaboration: Work with scientists, clinicians, and quality assurance teams to refine product concepts and move them from the research phase to commercialization. Participate in regular project meetings to ensure timelines, budgets, and objectives are met.

Clinical & Preclinical Testing: Support the design and execution of preclinical and clinical studies, ensuring that data collected is robust and aligned with development goals. Analyze results and make recommendations for product enhancements.

Innovation & Market Trends: Stay up-to-date with emerging trends in regenerative medicine and biotechnology. Identify opportunities for innovation and contribute to the strategic direction of new product development.

Documentation & Reporting: Maintain accurate and thorough documentation throughout the development process, ensuring compliance with internal and external quality systems. Present regular updates on project status to senior management and stakeholders.

Manufacturing & Production Support: Provide technical support to the manufacturing team, ensuring smooth transition from the development phase to commercial-scale production. Troubleshoot production issues and support process improvements.

Risk Management & Mitigation: Identify potential risks associated with product development and implement strategies to mitigate them. Ensure product safety and efficacy are prioritized throughout all stages of development.

Continuous Improvement: Drive continuous improvement initiatives in product development, incorporating feedback from clinical trials, customer usage, and market data to refine and optimize regenerative medicine products.

What the Client is Looking for in You

As the Regenerative Medicine Product Development Engineer, the client is seeking a highly skilled and driven professional with a strong background in biomedical engineering and regenerative medicine. You should be passionate about advancing healthcare through innovative solutions, with a proven ability to contribute to the development of cutting-edge medical products.

Strong Technical Expertise in Regenerative Medicine

The client is looking for a candidate with solid technical expertise in regenerative medicine, biomedical engineering, or related fields. You should have hands-on experience in product development, including the design, optimization, and commercialization of regenerative therapies. Your ability to tackle complex technical challenges and contribute to the innovation of life-changing treatments is key to this role.

Experience in Product Development & Lifecycle Management

You should have demonstrated success in managing the full product development lifecycle from concept to commercialization. The client values candidates with experience in preclinical and clinical stages of development, along with a strong understanding of regulatory requirements and compliance. Experience in managing the transition from prototype to manufacturing at scale is highly sought after.

Strategic and Analytical Thinking

The client values a strategic thinker who can analyze market trends, identify opportunities for innovation, and develop long-term solutions for regenerative medicine products. Your ability to evaluate complex data, optimize development processes, and propose actionable strategies will be essential to driving the company’s goals forward.

Strong Knowledge of Regulatory and Compliance Standards

A deep understanding of FDA regulations, GMP, and industry standards is essential for this role. The client is looking for someone who can navigate the complex regulatory landscape and ensure all products meet the necessary compliance requirements. Experience in preparing and submitting regulatory documentation is highly desirable.

Collaboration & Cross-Functional Leadership

This role requires a collaborative approach, as you will work closely with scientists, clinicians, and cross-functional teams to develop innovative products. The ability to communicate effectively, drive team alignment, and contribute to a culture of innovation and continuous improvement is critical for success in this position.

Dedication to Patient-Centric Solutions

The client is looking for a candidate who understands the impact of regenerative medicine on patient outcomes. You should be committed to designing products that prioritize patient safety and efficacy while also considering the broader healthcare landscape. A passion for improving patient lives and transforming healthcare is a core requirement.

Commitment to Innovation and Continuous Learning

Finally, the client values professionals who are continuously seeking to expand their knowledge and stay ahead of industry trends. You should have a keen interest in emerging technologies and new advancements in regenerative medicine, driving innovation and ensuring that the company remains at the forefront of medical breakthroughs.

FAQs About the Role – Regenerative Medicine Product Development Engineer – Cambridge, MA

1. What are the key responsibilities of the Regenerative Medicine Product Development Engineer?

As the Regenerative Medicine Product Development Engineer, you will be responsible for leading the design and development of cutting-edge regenerative medicine products. Your role includes overseeing the entire product development lifecycle from concept through commercialization, optimizing manufacturing processes, ensuring regulatory compliance, and collaborating with cross-functional teams. You will also support clinical and preclinical testing, manage product risks, and contribute to ongoing innovation in regenerative medicine technologies.

2. What qualifications and experience are required for this position?

The ideal candidate should have a degree in Biomedical Engineering, Regenerative Medicine, or a related field, with substantial experience in product development within the medical or biotechnology industries. A strong background in regenerative therapies, FDA regulations, and Good Manufacturing Practices (GMP) is essential. Experience in both preclinical and clinical phases of product development, as well as proficiency in troubleshooting technical challenges, is highly valued. A Master’s or PhD in a relevant field is a plus.

3. What technical skills are important for this role?

The candidate should have a solid understanding of regenerative medicine technologies, such as stem cells, tissue engineering, and gene therapy. Proficiency in engineering principles, product design, and development tools is required, along with expertise in regulatory affairs related to medical product development. Additionally, familiarity with statistical analysis, data interpretation, and clinical trial design will be beneficial for ensuring product success.

4. What challenges can I expect in this role?

This role comes with challenges typical of the regenerative medicine industry, including overcoming technical barriers in product development, ensuring regulatory approval, and managing the complexities of clinical testing. You will also need to navigate the evolving landscape of regenerative medicine, adapting to emerging technologies and market demands while balancing innovation with safety and compliance.

5. What is the expected impact of the Regenerative Medicine Product Development Engineer on the company’s growth?

Your contribution will have a direct impact on the company’s ability to develop and bring new regenerative medicine products to market. By driving innovation, ensuring product quality, and meeting regulatory requirements, you will play a key role in enhancing the company’s product portfolio and positioning it as a leader in regenerative healthcare solutions.

6. What is the company’s culture and work environment like?

The company promotes a collaborative, dynamic, and innovation-driven work environment. You will be part of a passionate team focused on advancing regenerative medicine, where creativity, scientific discovery, and teamwork are highly valued. The work culture encourages continuous learning, professional growth, and a commitment to improving patient outcomes.

What Remuneration Can You Expect from This Job?

As a Regenerative Medicine Product Development Engineer in Cambridge, MA, you can expect a competitive and attractive compensation package, reflecting the specialized nature of this role in a fast-evolving industry. The remuneration for this position typically includes:

1. Base Salary
The base salary for a Regenerative Medicine Product Development Engineer in this role varies depending on your experience, expertise, and the specific company. For mid-level professionals, the annual base salary typically ranges from $85,000 to $130,000. Senior-level engineers with specialized skills in regenerative medicine may earn upwards of $150,000 annually, with top-tier organizations offering even higher salaries based on their market position.

2. Performance-Based Bonuses
In addition to your base salary, you can expect performance-based bonuses tied to the success of product development milestones, company growth, and individual contributions. These bonuses can range from 10% to 30% of your base salary, rewarding you for meeting or exceeding goals related to product quality, regulatory compliance, and innovation.

3. Stock Options & Equity
Many companies in the biotechnology and regenerative medicine space offer stock options or equity grants as part of their compensation package. These grants may include restricted stock units (RSUs) or performance shares, which align your incentives with the company’s long-term success. Depending on the company’s valuation, equity-based compensation can be a significant part of your total earnings and provide long-term financial rewards.

4. Profit-Sharing & Long-Term Incentive Plans (LTIPs)
Some companies offer long-term incentive plans (LTIPs) or profit-sharing programs that reward employees for the company’s sustained performance. These plans ensure that your financial rewards are tied to the company’s success over time, offering additional incentives based on the company’s growth, product success, and market impact.

5. Executive Benefits & Perks
In addition to salary and bonuses, you will likely receive a comprehensive benefits package, which could include:

Health, dental, and vision insurance
401(k) retirement plans with company matching
Life and disability insurance
Paid time off (PTO) and holidays
Wellness programs and gym memberships
Travel and expense allowances

6. Relocation Assistance
For candidates relocating to Cambridge, MA, the company may offer relocation assistance to ease the transition. Relocation packages may cover moving expenses, temporary housing, and other associated costs, depending on the level of the position and your relocation needs.

Total Compensation Potential

When combining your base salary, performance bonuses, equity incentives, and benefits, the total annual compensation for a Regenerative Medicine Product Development Engineer can range from $95,000 to over $170,000, depending on your experience, the company’s compensation structure, and performance. Top-tier companies and senior-level candidates can expect even more lucrative compensation packages.

How to Apply

If you are an innovative and results-driven engineer with a passion for regenerative medicine, we invite you to apply for the Regenerative Medicine Product Development Engineer position in Cambridge, MA. This is an exciting opportunity to contribute to the development of life-changing products in the healthcare industry and play a pivotal role in advancing regenerative therapies.

To apply, please submit your updated resume and a cover letter detailing your experience in regenerative medicine, biomedical engineering, product development, and regulatory compliance. Highlight your skills in leading the product lifecycle, solving complex technical challenges, and collaborating across teams. We are looking for candidates who are committed to driving innovation and making a meaningful impact in the field of regenerative medicine.

This role offers a unique chance to be at the forefront of cutting-edge medical technologies while working in a dynamic and collaborative environment. Apply today to take the next step in your career as a Regenerative Medicine Product Development Engineer in Cambridge, MA!

For more information or to explore similar opportunities, visit our Regenerative Medicine Careers page.

Job Category: Medical Device

Job Type: Full Time

Job Location: Cambridge

Regenerative Medicine Product Development Engineer – Cambridge, MA