Staff Engineer

New Today

Description
: Roles & Specific Responsibilities Lead/serve as a core team member representing R&D function in a cross-functional team environment to release design control deliverables to support the development, improvement, and commercialization of new and improved products. Build, develop, own, and execute technical strategies on projects. Manage/Coach the extended team for duration of project and effectively allocate work within the project. Manage stakeholders within projects to ensure technical strategies, risks, and decisions are understood and aligned. Serve as SME in product development and design change control process in accordance with 21 CFR Part 820 & ISO 13485. Support regulatory submissions as technical lead. Own project deliverables from Design Inputs to Design Transfer, leveraging expertise from extended team members. Facilitate and own technical decisions and recommendations.
Requirements: B.S. degree or higher in engineering or related fields with the following years of experience
B.S. degree with a minimum of 5+years of experience, or Advanced Degree w/2-3 years of experience.
Proven experience in product development with experience developing and releasing products to market or releasing large sustaining projects to market.
Expertise with design controls (21 CFR Part 820, ISO 13485) & risk management (ISO 14971).
Working experience in medical device regulations and submission processes.
Excellent communication of technical and complex problems to all levels of organization.
Demonstrated ability to lead teams and influence others.
Ability to evaluate, compare, and make trade-off decisions.
Ability to manage complex data.
Preferred Knowledge and Skills: Exceptional team leadership skills, and ability to motivate and inspire others .
Foundational understanding in one or more of the following areas: Design for Six Sigma (DFSS) MBSE/SysmL & Requirements Management. Statistical tools, methodolgoies and applications (e.g., Minitab, R)
Working experience in one or more of the following areas: Design verification planning, testing, and test method development. Data analytics (python, powerBI, databricks, SAP) Plastics design and/or fluid mechanics. High volume design & manufacturing.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. 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.
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Location:
Brea

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