Job Title: Medical Device Laser Engineer
Job Summary: We are seeking a talented and motivated Medical Device Laser Engineer to join our dynamic team. The ideal candidate will have a strong background in laser engineering and a passion for developing cutting-edge medical devices. As a Medical Device Laser Engineer, you will play a key role in the design, development, and testing of laser-based medical devices aimed at improving patient outcomes and advancing healthcare technology.
Responsibilities:
- Design and develop laser-based medical devices from concept to commercialization, ensuring compliance with regulatory requirements and industry standards.
- Conduct feasibility studies and technical assessments to evaluate the viability of new laser technologies for medical applications.
- Collaborate with cross-functional teams, including electrical engineers, mechanical engineers, physicists, and biomedical scientists, to integrate laser systems into medical devices.
- Perform optical and laser system design, simulation, and optimization using software tools such as Zemax, MATLAB, or equivalent.
- Conduct experimental testing and validation of laser systems, analyzing data and providing recommendations for improvements.
- Participate in risk analysis, failure mode and effects analysis (FMEA), and design verification and validation activities.
- Provide technical expertise and support to manufacturing, quality assurance, and regulatory affairs teams during product development and production phases.
- Stay abreast of emerging trends and advancements in laser technology, medical device regulations, and industry best practices through continuous learning and professional development activities.
- Contribute to intellectual property generation through invention disclosures, patent applications, and technical publications.
Qualifications:
- Masters degree in Laser & Optics, Photonics, Physics with laser background
- Proven experience in the design, development, and testing of laser systems, preferably in the medical device industry.
- Proficiency in optical design software such as Zemax, Code V, or equivalent.
- Strong understanding of laser physics, including laser sources, optics, and beam delivery systems.
- Hands-on experience with laser safety protocols and laser safety certifications (e.g., CDRH, IEC 60825).
- Familiarity with medical device regulations and standards, such as FDA 21 CFR Part 820, ISO 13485, and IEC 60601.
- Excellent problem-solving skills and the ability to work effectively in a multidisciplinary team environment.
- Effective communication skills, with the ability to present complex technical information clearly and concisely.
- Strong organizational skills and attention to detail, with the ability to manage multiple projects simultaneously.
Preferred Qualifications:
- Minimum 5 years of Experience with medical device product development processes, including design controls and risk management.
- Knowledge of laser-tissue interactions and laser-based therapeutic modalities.
- Experience with laser system integration into medical imaging devices.
- Previous experience in a regulated industry environment, preferably in medical device .