Job description summary
Staff quality engineer with software design quality experience
Job description
Be part of something bigger!
Bd is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of careWe have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
As directed by the quality manager, the staff quality engineer i is accountable for supporting new product development and product maintenance through the application of quality engineering skills for medical device products incorporating software/firmwareThis person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the software development processes to ensure products meet quality standards consistent with both corporate and unit policies, while meeting all design control and other regulatory requirementsThis is a home-based role with remote/hybrid options!
Primary responsibilities:
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 (e.gSme, etc.)
Writes and leads risk management activities including risk management reports and risk analyses.
May perform other duties as required
Guides the successful completion of major programs and may function in a project leadership role.
Provides management with review opportunities at key points and upon completion.
Ensures quality conduct of projects, including design, data summary and interpretation, report and manuscript preparation and review adherence to applicable regulations.
Decisions, recommendations and results further the achievement of goals critical to organizational objectives
Implements and communicates the strategic and technical direction for the product/project team
Maintain/create procedures, policies and quality plans to stay in compliance with local/global regulations and corporate quality system requirements.
Identifies any issues that may delay product or project and recommends appropriate action to be taken
Position specific overview:
Understand the software development (sw) and testing life cycle as defined by iec 62304.
Experience supporting sw-related r&d design change efforts through development and/or testing.
Understanding of sw issues tracking, automation, issues tracking, risk assessment and bug containment.
Provide coordination and guidance to cross-functional teams to ensure software quality objectives are met for product software, manufacturing software, quality system software, and software technologies included or used in the creation or production of medical devices.
Reviews and approves project documentation including software development plans, software requirements specifications, software design documents, software test plans/protocols/reports.
Requirements:
Must have engineering degree
Extensive knowledge of applicable regulatory, corporate and/or unit requirements.
8-10+ years experience preferred
Embedded software validation experience preferred
Capital equipment validation preferred
Experience with risk management preferred
Experience working with cross-functional teams and remote teams
Prefer infusion pump experience or drug delivery experience (regulated fda industry)
Why join us?
A career at bd means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to workHere our associates can fulfill their life’s purpose through the work that they do every dayYou will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding cultureOur total rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about bd visit https://jobs.bd.com/
Becton, dickinson and company is an equal opportunity/affirmative action employerWe do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary work location
Usa ca - san diego tc bldg c&d
Additional locations
Work shift
Na (united states of america)
