The Requirements
To be a good fit for the role you should have:- A Bachelor of Science degree or higher in Engineering or a similar discipline
- 10 years minimum Medical Devices Device experience with a minimum of 5 years of Quality experience or design control experience, including experience in leading design control and risk management activities. Experience in supplier management is a plus. Quick question for you - click here
- Systems and/or software experience is a plus
- In-depth understanding of Design Control and Risk Management
- Working knowledge of the requirements of FDA QSRs, ISO 13485 and ISO 14971
- Experience in supplier management is a plus
- Certification as an internal lead auditor for QSRs and/or ISO 13485 is a plus
- Well versed in statistical analytical methods
- Proficiency in Microsoft Office applications; experience in Minitab, JMP or similar statistical package
- Excellent oral and written communication skills; strong presentation skills
- Demonstrated capabilities in creating Design Control documentation
- A team player approach with a collaborative mindset Quick question for you - click here
The Role
Reporting to the Senior Manager, Quality Systems, as Principal Quality Engineer, you will lead design assurance and risk management activities to support the development of unique medical devices in collaboration with some of the world’s leading medical institutions. We are working together to develop innovative medical optical imaging technologies that, when brought to market, will serve a variety of applications and provide innovative diagnostic and treatment solutions. Quick question for you - click hereOn a daily basis you will work collaboratively with design engineers, providing guidance and mentorship, and participating on design control and risk management efforts. Your statistical analysis skills will be a valued asset. You will have the opportunity to help establish the Quality System infrastructure. Additionally, you will review and approve design control, risk management and quality system documentation. You will meet with top doctors, research and other hospital personnel, and attend multiple meetings.
Specifically, your key responsibilities will be to:
- Work collaboratively with R&D engineers providing guidance and participation in design inputs, design and development planning, design reviews, design verification and validation, and design transfer efforts. Review and approve design control and product documentation.
- Facilitate risk management activities including risk management plans, system risk assessments, and FMEAs.
- Provide guidance on the selection of statistical analyses and sample size for design verification and validation and other testing.
- Support successful transfer of products to manufacturing by ensuring the adequacy of process validation, design transfer plans, quality plans and supplier documentation.
- Document, implement and manage quality system processes.
- May plan and execute internal audits against applicable quality system standards, regulations and internal requirements.
- May conduct supplier quality management efforts for critical suppliers, including supplier approval, supplier audits and developing quality agreements.
Why Us
Work with innovative technology -- you will leverage your you skills and experience to drive products through the full lifecycle, moving them to market.Great team environment -- we are a small dedicated team that both enjoys and supports one another. We foster a positive and cohesive work environment and welcome another team member who desires the same. Because you'll bring a strong medical devices background, we will look to you to guide others and share your industry experience with the group.
Professional development and support -- while you will come in with a depth of knowledge and experience, there is a tremendous amount of room for growth in this unique position. While you'll mentor and guide the engineers you work with, providing them with professional growth opportunities, you will also have opportunities to advance your own skills through classes, exposure to new technologies and other training and mentorship from your manager.
A philosophy of diversity -- we embrace diversity in the workplace through the spirit of kyosei, Canon’s corporate philosophy. Kyosei means “all people, regardless of race, religion or culture, harmoniously living and working together into the future.” We are committed to creating a diverse work environment where all employees are respected and supported to do their very best. We are an Affirmative Action Equal Opportunity Employer M/F/D/V.
Innovation in technology -- we are one of the most prolific inventors of consumer and professional imaging solutions. Canon Inc. has maintained a top-five worldwide ranking among all companies issued U.S. patents.
Commitment to the community -- Canon U.S.A. believes strongly that we have a responsibility to contribute to the welfare of the communities we serve.
Excellent compensation -- in addition to a competitive salary, we offer a comprehensive benefits package that covers everything from your physical to financial well-being. Some highlights include a generous allotment of paid vacation and holidays, a profit sharing plan, a tuition reimbursement program, matching 401(k) contributions, parking, discounts on Canon products and more. Health benefits begin on your first day of employment.
Keys to Success
This is a multifaceted role in a busy and growing organization. Every day is different and you’ll have the opportunity to wear multiple hats managing everything from facilitating risk management and design control activities to ongoing mentorship to building infrastructure and developing QMS processes that will impact overall operations and future growth. Your success, in part, will be dependent on how well you help facilitate the growth of our team and organization through mentorship and collaboration in product development, risk management and in establishing the Quality System infrastructure.Because we are a small organization, flexibility and agility will be key. A cultural fit will also be essential. Canon promotes a culture of diversity and collaboration and that is especially true at Healthcare Optics Research Laboratory. You’ll be surrounded by smart and engaged professionals who are also a truly nice group of people working toward common goals. You will be part of a supportive environment that facilitates invention and innovation. If you enjoy taking a team-oriented approach and continually supporting your teammates, you’ll fit right in.