R&D Product Development Engineer

Biocomposites; Keele; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in medical devices seeks an R&D Product Development Engineer to manage technology transfers and ensure compliance with industry regulations. The role involves collaboration with cross-functional teams and requires strong project management skills. Competitive salary and benefits offered.

Benefits

Company events

Company pension

Employee discounts

Travel subsidies

Free parking

Qualifications

• At least 5 years of experience in technical transfer, process development, or manufacturing operations.
• Knowledge of ISO13485 and GMP regulations.

Responsibilities

• Manage transfer of technologies and products between R&D and manufacturing.
• Collaborate with cross-functional teams to ensure successful transfers.
• Ensure compliance with regulatory and quality standards.

Skills

Problem-Solving

Communication

Project Management

Education

Degree level 6 in Engineering

Degree in Chemistry

Degree in Biotech

Degree in Pharmaceutical Sciences

Job description

Job Description

Biocomposites, Ltd. is an international medical devices company that engineers, manufactures, and markets world-leading products for infection management in bone and soft tissue. Based in Keele, Staffordshire, UK, it operates globally across Europe, USA, Canada, Argentina, China, and India, helping over 1 million patients worldwide annually.

Our team focuses solely on developing innovative calcium compounds, with all research, manufacturing, and distribution centered at our headquarters in Keele. In 2022, we received two Queen’s Awards for Enterprise in Innovation and International Trade, recognizing the impact of STIMULAN and our growth, with overseas sales increasing over 200% in six years. Our products are used in more than 120,000 procedures annually and sold in over 40 countries.

R&D Product Development Engineer

The role involves facilitating the transfer of technologies, processes, and products across different stages of the product lifecycle, ensuring seamless handovers from R&D to manufacturing, with compliance to industry regulations. This requires close collaboration with cross-functional teams to complete documentation, training, and validation activities.

Responsibilities

1. Manage transfer of intellectual property, design specifications, manufacturing processes, products, and technologies between R&D and manufacturing, and across facilities.
2. Plan and manage projects involving intellectual property, design modifications, upgrades, and technology transfers.
3. Collaborate with R&D, quality assurance, manufacturing, and regulatory teams to ensure successful transfers.
4. Ensure compliance with regulatory and quality standards in product development and manufacturing processes.
5. Support process development, scale-up activities, and troubleshooting.
6. Lead process design reviews, risk assessments, and validation activities.
7. Develop, review, and approve technical documents such as protocols, reports, and SOPs.
8. Train manufacturing staff on new technologies and processes.
9. Track progress, timelines, and issues in transfer projects.
10. Troubleshoot technical issues during transitions and implement solutions.
11. Coordinate with regulatory teams for filings and approvals.
12. Maintain process data, documentation, and reports per company standards.
13. Occasional travel to sites, vendors, or partners may be required.

Person Specification

• Degree level 6 in Engineering, Chemistry, Biotech, Pharmaceutical Sciences, or related field.
• At least 5 years of experience in technical transfer, process development, or manufacturing operations.
• Knowledge of ISO13485 and GMP regulations.
• Strong problem-solving and troubleshooting skills.
• Excellent communication and project management skills.
• Ability to work in cross-functional teams and manage multiple projects.
• Experience with process scale-up, validation, and optimization.
• Attention to detail and organizational skills.
• Familiarity with risk management and quality assurance processes.
• Project management certification is desirable.

What We Offer

Competitive salary and benefits! We provide a competitive package and benefits.

We grow talent. Opportunities to develop and advance your career.

One Biocomposites - team spirit & engagement. We foster an inclusive, collaborative culture that values diverse perspectives.

Who Are We Looking For?

People passionate about our mission. Open-minded individuals eager to evolve and improve.

Team players who want to make a difference. Collaborators committed to transforming outcomes and lives.

Benefits

• Company events
• Company pension
• Employee discounts
• Travel subsidies
• Free parking