Principal Supplier Quality Engineer

Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital-to-home. By putting the needs of patients and physicians first, our personalized digital devices, which are designed for function, comfort, and ease-of-use, aim to redefine the paradigm of care for these patients. Our first product, a wearable patch defibrillator, is initially targeted at treating the more than 500,000 patients in the US with an elevated temporary risk of potentially experiencing a lethal heart rhythm. Based in San Francisco, our funders include Third Rock Ventures, Google Ventures, Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.

SUMMARY OF ROLE:

Element Science is establishing a top-notch team for designing and manufacturing medical devices. We are seeking a Principal Supplier Quality Engineer who is dedicated to working on life-saving devices. This individual will aid the product development and operations team in identifying, qualifying, and cultivating suppliers in line with ISO 13485 requirements. They will be responsible for providing quality support and oversight to ensure that the products are developed in compliance with company SOPs and other regulatory requirements. The ideal candidate should possess excellent interpersonal skills and a can-do attitude to deliver solutions.

RESPONSIBILITIES:

• Manage control of external suppliers and contract manufacturers to ensure the supply of quality materials

• Develop procedures and best practices for supplier management

• Act as the quality representative in external supplier communications

• Lead supplier qualification program and maintain an up-to-date Approved Supplier List

• Generate supplier-related metrics and execute data-driven improvements

• Communicate supplier-related issues to responsible supplier representatives and facilitate the resolution of supplier issues through quality process e.g., SCAR

• Support improvement of supplier processes through audits and feedback to suppliers

• Collaborate with suppliers on the creation and maintenance of quality tools such as FMEAs, control plans

• Support improvement of Standard Operating Procedures and/or Work Instruction as part of the Quality System procedure

• Mentor junior engineers

• Other tasks as assigned by the management

QUALIFICATIONS:

• 10+ years of relevant experience in a Medical Device environment

• Bachelor's Degree in Science or Engineering, Master's degree is a plus.

• Experience with electronics manufacturing, injection molding preferred

• Working knowledge of current ISO 13485 standard, QSR, and ISO 14971

• Ability to work in a team environment, manage multi-tasking, and be disciplined in completing tasks on schedule

• Excellent written and verbal communication skills

BENEFITS:

Element Science offers a very competitive salary and benefits package including, but not limited to:

• Stock Options

• 90% employer-paid medical, dental, and vision insurance

• Company-paid Basic Life Insurance

• 401(k) retirement plan (Traditional and Roth)

• Competitive Paid Time Off

• Paid Holidays

• FSA (Flexible Spending Accounts)

• HSA (Health Savings Account)

• Employee Assistance Program through PEO

The salary for this exempt-level position will be based on experience and qualifications within an established pay range.

• Pay range: $170,000 to $183,000

Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job.

At this time, we are unable to offer relocation assistance at Element Science.