BD Nogales Norte
Associate Staff Engineer - Sustaining
BD Nogales Norte, Salt Lake City, Utah, United States, 84193
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description Summary Associate Staff Engineer - Sustaining
Summary The Associate Staff Sustaining Engineer will support new product development and sustaining engineering activities of vascular access devices in all stages of the product life cycle. This includes supporting design, testing, manufacturing, clinical evaluation, regulatory clearance/approval, marketing, sales, training, and post‑market surveillance. The candidate will be responsible for ensuring products are safe and effective by developing test methods, executing device evaluations, interpreting data results, authoring technical documents, and presenting findings to management. In addition, the individual will be responsible for communicating requirements to suppliers and managing external resources to meet project milestones on time and within budget. The ideal candidate should have experience in the medical device industry or related field. Knowledge of FDA regulations, IEC standards, ISO 10993, and quality system requirements such as MDSAP would be beneficial. Experience with design control process, risk analysis, and conducting human factors studies is required.
Responsibilities
Supports all phases of new product development and sustaining engineering activities including design, testing, manufacturing, clinical evaluation, regulatory clearance/approval, marketing, sales, training, and post‑market surveillance.
Develops and updates user documentation (e.g., specifications, protocols, reports) according to applicable FDA regulations, IEC standards, ISO 10993, and quality system requirements.
Manages external resources to ensure timely completion of projects. Communicates requirements to suppliers and ensures they are met.
Works closely with multi‑functional teams to execute project plans.
Performs activities in compliance with SOPs and other quality systems requirements.
Participates in audits and inspections as needed.
Applies fundamental knowledge of engineering fundamentals.
Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.
Reports to Manager, Sustaining Engineering.
Qualifications
Bachelor’s degree in Engineering or Science discipline plus minimum of 8 years relevant experience OR Master’s degree in Engineering or Science discipline plus 6 years relevant experience.
Medical device industry experience preferred.
Ability to understand complex business processes and develop efficient solutions.
Strong communication skills (written and verbal).
Ability to travel domestically and internationally approximately 5% of time.
Proficient computer skills (Microsoft Office Suite).
Demonstrated ability to handle multiple competing priorities simultaneously while meeting deadlines.
Ability to interpret data, draw reasonable conclusions, and make sound decisions based upon available information.
Familiarity with Design Control Process and Risk Analysis.
Working knowledge of FDA regulations (21 CFR Part 820), IEC Standards (60601 series), ISO Standards (14971, 13485, 10993), and quality system requirements (MDSAP).
Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive and find satisfaction in doing your part to make the world a better place.
Location: Salt Lake City, UT (USA). Full‑time position.
To learn more about BD visit https://bd.com/careers
BD is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics.
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Job Description Summary Associate Staff Engineer - Sustaining
Summary The Associate Staff Sustaining Engineer will support new product development and sustaining engineering activities of vascular access devices in all stages of the product life cycle. This includes supporting design, testing, manufacturing, clinical evaluation, regulatory clearance/approval, marketing, sales, training, and post‑market surveillance. The candidate will be responsible for ensuring products are safe and effective by developing test methods, executing device evaluations, interpreting data results, authoring technical documents, and presenting findings to management. In addition, the individual will be responsible for communicating requirements to suppliers and managing external resources to meet project milestones on time and within budget. The ideal candidate should have experience in the medical device industry or related field. Knowledge of FDA regulations, IEC standards, ISO 10993, and quality system requirements such as MDSAP would be beneficial. Experience with design control process, risk analysis, and conducting human factors studies is required.
Responsibilities
Supports all phases of new product development and sustaining engineering activities including design, testing, manufacturing, clinical evaluation, regulatory clearance/approval, marketing, sales, training, and post‑market surveillance.
Develops and updates user documentation (e.g., specifications, protocols, reports) according to applicable FDA regulations, IEC standards, ISO 10993, and quality system requirements.
Manages external resources to ensure timely completion of projects. Communicates requirements to suppliers and ensures they are met.
Works closely with multi‑functional teams to execute project plans.
Performs activities in compliance with SOPs and other quality systems requirements.
Participates in audits and inspections as needed.
Applies fundamental knowledge of engineering fundamentals.
Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.
Reports to Manager, Sustaining Engineering.
Qualifications
Bachelor’s degree in Engineering or Science discipline plus minimum of 8 years relevant experience OR Master’s degree in Engineering or Science discipline plus 6 years relevant experience.
Medical device industry experience preferred.
Ability to understand complex business processes and develop efficient solutions.
Strong communication skills (written and verbal).
Ability to travel domestically and internationally approximately 5% of time.
Proficient computer skills (Microsoft Office Suite).
Demonstrated ability to handle multiple competing priorities simultaneously while meeting deadlines.
Ability to interpret data, draw reasonable conclusions, and make sound decisions based upon available information.
Familiarity with Design Control Process and Risk Analysis.
Working knowledge of FDA regulations (21 CFR Part 820), IEC Standards (60601 series), ISO Standards (14971, 13485, 10993), and quality system requirements (MDSAP).
Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive and find satisfaction in doing your part to make the world a better place.
Location: Salt Lake City, UT (USA). Full‑time position.
To learn more about BD visit https://bd.com/careers
BD is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics.
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