Product Development Engineer
On behalf of our client, a growing medical devices company, we are currently recruiting for a Product Development Engineer.
The role focuses on designing, developing, and optimizing medical devices to treat tinnitus. The ideal candidate will work closely with cross-functional teams to ensure successful product development deliverables.
Reporting to: VP of Global Operations
Key Responsibilities:
* Lead product development activities from design and prototyping to testing, validation, and commercialization for tinnitus treatment devices.
* Collaborate with operations, QA/RA, technical support, and commercial teams to ensure smooth product development and compliance with industry standards.
* Partner with the product manager to define product strategies and requirements.
* Define technical requirements and develop design inputs for new products.
* Work on embedded systems, firmware, and software development to ensure seamless integration into the medical device.
* Perform risk assessments and contribute to the creation of product development documentation.
* Work closely with product development and manufacturing teams to optimize designs for production and scalability.
* Manage the product development lifecycle to ensure timelines are met and products meet regulatory requirements and quality standards.
* Participate in design reviews, prototype testing, and provide technical support to other departments.
* Assist in troubleshooting and providing technical solutions for product-related issues.
Required Skills & Qualifications:
* Engineering degree with at least 5 years of experience in product development engineering, preferably in medical devices or related fields.
* 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.
* Hands-on experience in product design, prototyping, and testing, including hardware and software components.
* Strong knowledge of mechanical engineering principles, materials, and manufacturing processes, along with software development principles.
* Familiarity with risk management techniques and product validation processes.
* Ability to collaborate effectively with cross-functional teams.
* Proficient in CAD software and other engineering tools for product development and software/firmware development tools.
* 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.
Preferred Qualifications:
* Experience with hearing aids, implants, or other auditory technologies.
* Familiarity with 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.
Desirable Skills and Knowledge:
* Global perspective with the ability to work effectively in multi-disciplinary teams.
* Continuous improvement mindset and experience, including Six Sigma/Lean Manufacturing.
* Strong attention to detail and commitment to quality.
* Ability to train and mentor 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 mitigating risk.
* Flexibility to work in a dynamic, fast-paced, and rapidly evolving medical device environment.
* Willingness to travel internationally as required.