Product Development Engineer Medical Devices

Product Development Engineer

We are seeking a highly skilled and motivated Product Development Engineer to join our team at CPL Healthcare. This engineering role will focus on the design, development, and optimization of medical devices aimed at improving the lives of individuals with tinnitus.

1. Lead product development activities from design and prototyping to testing, validation, and commercialization for tinnitus treatment devices, including both hardware and software components.
2. Collaborate cross-functionally with Operations, QA/RA, Technical Support, and Commercial teams to ensure smooth product development and compliance with industry standards.
3. Partner with the Product Manager to define product strategies and requirements, ensuring alignment with business goals and market needs.
4. Define technical requirements, conduct feasibility studies, and develop design inputs for new products.
5. Work on embedded systems, firmware, and software development to ensure seamless integration into the medical device.
6. Perform risk assessments and contribute to the creation of product development documentation, including design history files (DHF) and technical files.
7. Work closely with product development and manufacturing teams to ensure designs are optimized for production and scalability.
8. Manage the product development lifecycle to ensure timelines are met and products are developed to meet regulatory requirements and quality standards.
9. Participate in design reviews, prototype testing, and provide technical support to other departments throughout the product lifecycle.
10. Assist in troubleshooting and providing technical solutions for product-related issues in both development and post-market stages.

• Engineering degree with a minimum of 5 years of experience in product development engineering, preferably in medical devices or related fields (e.g. hearing technology or similar industries).
• Strong experience in embedded systems, firmware, and software development for medical devices.
• Experience in developing and launching medical devices, with a strong understanding of design controls and regulatory requirements (e.g., FDA, ISO 13485).
• Hands-on experience in product design, prototyping, and testing, including both hardware and software components.
• Strong knowledge of mechanical engineering principles, materials, and manufacturing processes, along with software development principles.
• Familiarity with risk management techniques (e.g., FMEA) and product validation processes.
• Ability to collaborate effectively with cross-functional teams, including operations, regulatory, quality assurance, commercial teams, and product managers.
• Proficient in CAD software and other engineering tools for product development (e.g., SolidWorks, AutoCAD, MATLAB) and software/firmware development tools (e.g., C/C++, Python, embedded systems).
• Strong problem-solving, critical thinking, and decision-making skills.
• Excellent communication skills, both written and verbal.
• Detail-oriented, proactive, adaptable, with a focus on continuous improvement and patient outcomes.

• Experience with hearing aids, implants, or other auditory technologies.
• Familiarity with the FDA's 21 CFR Part 820 or ISO 13485 standards.
• Knowledge of ISO 14971 and other relevant medical device standards.
• Experience with product lifecycle management software (e.g., PLM systems).

• Global perspective with the ability to work effectively in multi-disciplinary teams.
• Continuous improvement mindset & experience including Six Sigma/Lean Manufacturing.
• Strong attention to detail and commitment to quality.
• Ability to train and mentor other team members and guide them to resolutions.
• Strong analytical problem-solving skills and able to make efficient decisions.
• Proven track record for identifying and implementing improvements to products and mitigate risk.
• Flexibility to work in a dynamic, fast-paced, and rapidly evolving medical device environment.
• Willingness to travel internationally as required.