Johnson & Johnson Careers
Engineer, Design Control & DHF Management Lead
Requisition ID: 1307180511
Johnson & Johnson Surgical Vision (JJSV) is recruiting for an Engineer, Design Control & DHF Management Lead in Santa Ana, CA. JJSV designs, manufactures, and distributes products for the surgical treatment of anterior segment ophthalmic disorders, most notably cataract removal.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
The Johnson & Johnson Surgical Vision goal is improving sight throughout a patient’s lifetime. J&J Surgical Vision is well positioned to address a full range of vision health needs for global markets: The No. 2 global provider of CATARACT products and a leader in presbyopia-correcting IOLs, the Global REFRACTIVE (LASIK) market leader, all supported with a CONSUMER EYE HEALTH diverse portfolio of solutions and drops. Johnson & Johnson Surgical Vision has operations in the United States, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Our associates around the world are committed to expanding our brands and fortifying our position as the worldwide leader in the industry.
The primary responsibility of this individual is directly responsible for managing and maintaining the design control and related product design history files for J&J Vision Surgical product development programs. This ensures product design quality compliance and directly impacts the final product design safety, efficacy, and quality.
Adheres to environmental policy, procedures, and supports department environmental objectives. Engages in Credo-based decision-making.
You, the Engineer, Design Control & DHF Management Lead, will:
- Manage and maintain design control, risk management and design life cycle management in product development. (30%)
- Maintain all development design history files and be the interface with the quality team. (20%)
- Be an active product development member with focus on maintaining the product risk analysis and related management files. (20%)
- Collaborate with system quality process and usability specialists in applying and maintaining the standard operating procedures, guidelines and document templates. and providing direction regarding the development and design of quality systems including processes, documentation and computer records (10%)
- Represent R&D for design history quality audits. (10%)
- Leads and oversees the activities of engineers and support staff (10%).
- BS in STEM related engineering discipline is required.
- 2 years of experience in medical device Design Control documentation especially within Risk Management and Requirements Engineering is required
- Strong experience in medical device development, FDA 21 CFR Part 820and ISO 13485 is required
- Deep knowledge of regulatory requirements for medical devices in EU, US is desired
- Experience with complex products containing multiple interfacing components is preferred
- Excellent client facing and internal communication skills is required
- Solid organizational skills including attention to detail and multi-tasking skills is required
- PMP / PRINCE II certification is a plus.
- This position is located in Santa Ana, CA and may require up to 10% of travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-California-Santa Ana
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