Senior Director Human Factors and Risk Engineering
2 weeks ago
As the Bio-Rad's Senior Director of Global Human Factors and Risk Engineering, you will be responsible for establishing and managing Human Factors (HF) engineering processes. You will potentially standardize risk management (RM) practices across Bio-Rad, including RM for AI devices. Lead Quality and Regulatory (QARA) training. You will collaborate within QA/RA to refine HF processes for all new product development. Provide leadership with expertise in HF, UX design principles, and usability testing. Work with cross-functional teams to enhance Bio-Rad's HF Engineering process and evaluate RM procedures. Build a cohesive HF/RM presence, conduct user research, and oversee validation tests. Guide integration of HF into engineering functions and collaborate with various teams to prioritize safety and user experience. Develop strategies for QARA training in alignment with the QARA PMO.
How You Will Make an Impact:
- You will develop and implement HF/RM strategies to support business objectives and sustainable product safety and performance.
- Collaborate with cross-functional stakeholders to ensure their success in achieving financial results.
- Build executive support of global quality initiatives that ensure compliance with regulatory and customer requirements.
- Analyze the human factors process and procedures and develop/implement pragmatic solution delivering sustainable improvement. Analyze complaints data and deliver pragmatic sustaining engineering/design improvements.
- Ensure the company's usability engineering processes and methodologies meet and surpass the latest expectations of regulatory agencies;
- Create a list of deliverables for each stage of a product development lifecycle, that aligns with all business units and further evolve the design control processes.
What you Bring:
- You have a Master's degree in a relevant discipline such as Human Factors Engineering / Ergonomics, Usability Engineering, Cognitive/Experimental/Behavioral Psychology, Industrial Design, Engineering Psychology, Risk Management
- Minimum of 15 years of professional UX/HFE experience in developing regulated and non-regulated software and/or hardware and in performing verification & validation activities.
- Minimum of 7 years' experience as a functional manager in a User Experience & Human Factors organization.
- Experience in healthcare and FDA requirements in software design and development. Experience with pre-submissions, PMA & 510k submissions to the FDA. Experience in healthcare and FDA requirements in software design and development.
- Experience working in a matrixed environment and leadership of remote teams.
Total Rewards Package: At Bio-Rad, we're empowered by our purpose and recognize that our employees are as well. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle.
Benefits: We're proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG's), and more
Compensation: The estimated base salary range for this position is $221,000 to $304,000 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.
Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.
EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.
Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.
Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake "recruiters" and job scams. Click here for more information on this scam and how to avoid it.
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Legal Entity: (USA_1000)Bio-Rad Laboratories, Inc.
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