Quality Engineer II
Company: Element Science, Inc.
Location: Redwood City
Posted on: September 17, 2023
THE COMPANY: -
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.
- Provide Quality Engineering support to product development team
in the area of Design Control to ensure compliance to the QSR
Design control requirements.
- Participates in developing or improving Standard Operating
Procedures and/or Work Instruction as part of the Quality System
- Perform internal audit to various design and development areas
to ensure compliance to the QS SOP and WI.
- Responsible in managing Design Verification testing including
writing test protocols, execution of verification testing and
non-human design validation testing.
- Participates in cross-functional meetings with internal and
external parties as required.
- Participate in new supplier evaluation, work with suppliers to
ensure appropriate quality deliverables and activities are
implemented as needed.
- Facilitate NCR, CAPA and Complaints process execution.
- Supports management and tracking of quality system records
(e.g. DHF audit, Corrective and Preventive Actions, and
Effectiveness Checks) for adherence to organizational or
- Lead the development of DFMEA and Risk Analysis per ISO 14971
along with development team, support other activities such as Test
Method Validation on Design Verification Testing.
- Supports management review process through development and
generation of quality system metrics and generate quarterly data
for those metrics. Help the management in creating QMR presentation
slides for some QS elements as assigned.
- Implement appropriate Quality engineering practices including
statistical analysis, root cause analysis, and reliability
- Other tasks as assigned by the management.
- 4+ years of relevant experience in Medical Device environment
- Demonstrates working knowledge of current ISO 13485 standard
- Bachelor's Degree in Science or Engineering, Master's degree is
- Ability to work in a team environment, manage multi-tasking,
and discipline in completing tasks on schedule.
- Excellent written and verbal communication skills.
Element Science offers a very competitive salary and benefits
package including, but not limited to:
- Stock Options
- 90% employer-paid medical, dental, and vision
- 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
- Pay range: $100,000 - $120,000 (negotiable based on
Keywords: Element Science, Inc., Redwood City , Quality Engineer II, Engineering , Redwood City, California
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