The Quality Engineer will be responsible for quality responsibilities for new product development for hardware/software product systems for medical devices at Owlet. They will serve as the strategic and tactical lead for Owlet’s efforts associated with developing and sustaining Owlet’s quality needs. This includes processes to manage design and supplier quality for Owlet products and markets.
- As directed by the Sr. Director of Quality and Regulatory the Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with Owlet’s policies, while meeting all design control and other regulatory requirements.
- Extensive application of technical principles, theories, concepts and quality sciences, tools and systems with measurable / confirmed results.
- Track record of root cause determination and effective corrective / preventive action implementation.
- Provides training for product development teams and continuous improvement teams on best practices.
- Conducts audits as member of a quality system audit team
- Writes and leads risk management activities including risk management reports and risk analyses in accordance with ISO 14971
- Is an extended team member representing Quality on new product development projects and a team member for sustaining engineering projects.
- Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues.
- Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
- Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
- Plans and leads audits of suppliers to assess compliance with regulatory and Owlet’s requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
- Other responsibilities may include: Design control, Change control, Risk management, Process Validations, Identification of CTQ's, handling of deviations and non-conformances, test method validations, and supplier validations.
- Upto 30% domestic and international travel
Required Skills And Qualifications:
- Bachelor's Degree in engineering is required, preferably in electrical or biomedical engineering
- 2-5 years experience
- Direct experience in new product development of medical electrical devices
- Background in electrical applications - preferred
- Background in software validation preferred
- Experience in development of product risk analysis
- Design for reliability preferred
- Experience in defining qualification strategy
- Experience in design transfer
Owlet employees participate in quarterly evaluations that include:
- Performance feedback
- Behavioral feedback
- Training and development opportunities
- Manager feedback
- Competitive compensation based on experience
- Flexible schedules
- Paid holidays
- Product discounts
- 401(k) program with company match
- Eligible for company-sponsored benefits package 1st day of the month, following your hire date
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.