We are seeking a skilled and motivated Product Development Engineer II to join our dynamic team. In this role, you will be responsible for developing, designing, and optimizing Class III medical devices from concept through commercialization. You will work closely with cross-functional teams to ensure product performance, compliance, and manufacturability.
Key Responsibilities:
- Design & Development: Lead the design and development of Class III medical devices, including mechanical, electrical, and software components. Ensure that designs meet regulatory requirements and industry standards.
- Prototyping & Testing: Develop prototypes and conduct rigorous testing to validate product performance and reliability. Analyze test results and iterate on designs to address any issues.
- Regulatory Compliance: Collaborate with regulatory affairs to ensure that all product development activities comply with FDA regulations, ISO standards, and other applicable guidelines.
- Cross-Functional Collaboration: Work closely with R&D, manufacturing, quality assurance, and clinical teams to facilitate smooth product development and launch. Provide technical support and guidance throughout the development lifecycle.
- Project Management: Manage multiple projects simultaneously, ensuring timely completion within budget constraints. Prepare and maintain project documentation, including design history files and risk management reports.
- Continuous Improvement: Stay current with industry trends and advancements in medical device technology. Identify and implement process improvements to enhance product quality and development efficiency.
Qualifications:
- Education: Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field. A Master's degree is a plus.
- Experience: Minimum of 3-5 years of experience in product development, preferably within the medical device industry. Experience with Class III medical devices is highly desirable.
- Technical Skills: Strong proficiency in CAD software (e.g., SolidWorks, AutoCAD), knowledge of materials and manufacturing processes, and experience with design controls and risk management.
- Regulatory Knowledge: Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards.
- Problem-Solving: Excellent analytical and problem-solving skills with the ability to troubleshoot complex technical issues.
- Communication: Strong verbal and written communication skills, with the ability to effectively present ideas and collaborate with cross-functional teams.
- Attention to Detail: High level of accuracy and attention to detail in all aspects of work, from design to documentation.
