Owlet is changing the world of parenting with meaningful products that truly make a difference for millions around the world. Owlet has helped more than a million parents keep their children safe, while bringing joy and sleep to the parenting journey. We believe every parent deserves the peace of mind that comes with a better understanding of their baby’s needs.

Learn more about our amazing mission at https://owletcare.com/pages/why-owlet

As Quality Engineer I/II, you have the knowledge and skills to lead comprehensive risk management activities, including FMEA and risk assessments for design changes (under the supervision of the quality engineering manager), to ensure product safety and regulatory compliance. In addition to ensuring products consistently meet specifications and maintaining robust control over the manufacturing process to guarantee product quality, this is a fantastic opportunity to significantly impact the reliability and quality of our medical devices and consumer products from design through to distribution.

PRIMARY RESPONSIBILITIES:

• Ensure Design Control in accordance with 21 CFR 820 and ISO 13485 is implemented at appropriate phase gates in Medical Device development
• Ensure appropriate Design History Records are maintained in accordance with 21 CFR 820 and ISO 13485 for Medical Device development
• Identify and drive quality requirements and improvement opportunities in future & existing medical device and consumer products and manufacturing processes
• Lead Risk Management and FMEA activities for compliance in accordance with ISO 14971 for medical devices and consumer products
• Lead technical failure analysis to support root cause analysis and issue resolution for Corrective and Preventive Actions (CAPAs)
• Write technical reports related to design change qualifications, testing reports, risk assessments, etc
• Daily quality support for contract manufacturer & product supplier issues arising in incoming inspection, production, and product quality (including but not limited to NCMRs, Deviations, and FAIs)
• Investigates customer complaints to determine improvement projects and corrective actions
• Leads projects related to supplier complaint investigation (SCARs), CAPAs, cost reduction and quality system excellence
• Works closely with suppliers to ensure deliverance of high quality parts meeting specifications
• Support Process validations at contract manufacturer for both medical & consumer products
• Collaborate with cross-functional teams: Work closely with R&D, manufacturing, software & hardware design engineering, regulatory affairs, and other departments to ensure product quality.

REQUIRED SKILLS AND QUALIFICATIONS:

• Bachelor’s degree in Biomedical, Mechanical, or Electrical Engineering or related field (or equivalent experience) and 1-3+ years of work experience in medical devices
• You are detail oriented, well organized, able to work independently and on cross functional teams, adaptable, and results oriented with a positive attitude
• You have excellent judgment and integrity with the ability to make timely and sound decisions
• Proven ability to take ownership, solve problems proactively, and deliver results in a dynamic environment.

PREFERRED SKILLS AND QUALIFICATIONS:

• Experience with medical devices and ISO 13485
• Experience with Risk management (FMEAs, Risk assessments, RMPs, RMRs, etc) in compliance with ISO 14971
• Experience with Supplier Quality and control of manufacturing processes at contract manufacturers (NCMRs, Deviations, FAIs, etc)
• Strong Technical Writing Skills
• Experience with both Hardware and Software Quality Control

PERKS:

• Competitive compensation based on experience
• Flexible schedules
• Paid holidays
• Product discounts
• 401(k) Match
• Eligible for company-sponsored benefits package 1st day of the month, following your hire date

This role does not offer visa sponsorship.

Owlet Baby Care, Inc. is an equal opportunity employer, 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.