<link id='css--app'rel="stylesheet" href="/dist/css/app.min.css"> Opportunities – Trilogy

Opportunities

Quality Engineer (Medical Device) at Owlet Baby Care
Remote

Summary:

At Owlet, we are making a real difference in the lives of parents and their infants everyday through cutting-edge technology on the forefront of wearable tech, internet-of-things, and big data.

Owlet’s Quality Engineer will be the strategic and tactical lead for Owlet’s efforts associated with developing and sustaining Owlet’s quality needs

 

Primary Responsibilities:

Design Quality:

  • 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
  • Assist in medical device design review meetings to provide engineering and quality requirement subject matter expertise
  • Identify and drive quality requirements and improvement opportunities in future & existing medical device and consumer products and manufacturing processes
  • Generate Product Quality Plans for medical devices and consumer products
  • Lead Risk Management and FMEA activities for compliance in accordance with ISO 14971 for medical devices  and assist with review process FMEAs from OEM partners
  • Support FMEA activities for consumer products
  • Lead technical failure analysis to support root cause analysis and issue resolution for Corrective and Preventive Actions (CAPAs)
  • Manage quality escalation issues as directed by the Sr. Director of Quality Engineering and Regulatory Affairs
  • Conduct periodic reviews of Field/Factory Quality Data and drive compliance and improvement projects
  • Attend new product development builds, participate in OEM audits and other activities as required

 

Supplier Quality:

  • Conducts and coordinates external supplier audits as assigned to ensure QMS compliance
  • Daily quality support for issues arising in incoming inspection, production and product quality
  • In conjunction with corporate Quality System, reviews customer complaints to determine corrective action in regard to suppliers
  • Initiates and drives continuous process & yield improvement projects throughout Owlet’s supplier base
  • Leads projects related to supplier complaint investigation, CAPAs, cost reduction and quality system excellence
  • Works closely with suppliers to ensure the right parts meeting specifications are delivered on time

 

Required Skills and Qualifications:

Education

  • Bachelors in Electrical or Mechanical Engineering or related field preferred with 5+ years of experience
  • Associates degree with 7+ years of experience

Experience

  • 3+ year(s): Experience in medical device design 
  • Experience with supplier quality within a consumer product, consumer appliances, or other electro technical product category a plus

Experience

  • Detail oriented and well organized
  • Ability to work with cross-functional teams
  • Ability to act independently to solve complex problems
  • Experience writing procedures, and training others
  • Wide range of technical experience/skills
  • Use independent research to formulate action plans.
  • Understanding of database management and report generation a major plus

 

Perks:

  • Flex time scheduling
  • Competitive compensation based on experience
  • Benefits package
  • Product discounts

 

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.