Description
Roles & Specific Responsibilities
Lead / serve as a core team member representing R&D function in a multi-functional team environment to release design control work to support the development, improvement, and commercialization of new and improved products.
Build, develop, own, and implement 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 1-2+ 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.
At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role :
Annual Bonus
Health and Well-being Benefits
Medical coverage
Health Savings Accounts
Flexible Spending Accounts
Dental coverage
Vision coverage
Hospital Care Insurance
Critical Illness Insurance
Accidental Injury Insurance
Life and AD&D insurance
Short-term disability coverage
Long-term disability insurance
Long-term care with life insurance
Other Well-being Resources
Anxiety management program
Wellness incentives
Sleep improvement program
Diabetes management program
Virtual physical therapy
Emotional / mental health support programs
Weight management programs
Gastrointestinal health program
Substance use management program
Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit
Retirement and Financial Well-being
BD 401(k) Plan
BD Deferred Compensation and Restoration Plan
529 College Savings Plan
Financial counseling
Baxter Credit Union (BCU)
Daily Pay
College financial aid and application guidance
Life Balance Programs
Paid time off (PTO), including all required State leaves
Educational assistance / tuition reimbursement
MetLife Legal Plan
Group auto and home insurance
Pet insurance
Commuter benefits
Discounts on products and services
Academic Achievement Scholarship
Service Recognition Awards
Employer matching donation
Workplace accommodations
Other Life Balance Programs
Adoptionassistance
Backup day care and eldercare
Support for neurodivergent adults, children, and caregivers
Caregivingassistancefor elderly and special needs individuals
Employee Assistance Program (EAP)
Paid Parental Leave
Support for fertility, birthing, postpartum, and age-related hormonal changes
Leave Programs
Bereavement leaves
Military leave
Personal leave
Family and Medical Leave (FML)
Jury and Witness Duty Leave
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.
Staff Engineer • USA CA – Brea