Senior Design Quality Engineer

In-Office, Franklin Lakes, NJ

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Job ID: R-548981
Category: Engineering
Location: Franklin Lakes, Nova Jérsia

Construa uma carreira em engenharia onde inovação, autonomia e impacto impulsionam a saúde para frente

Na BD, profissionais de Engenharia e P&D projetam, desenvolvem e aprimoram as tecnologias que moldam como a saúde é entregue em todo o mundo. Você aplicará pensamento científico, expertise técnica e solução criativa de problemas para transformar desafios complexos em soluções que importam.

Seja você especialista em engenharia mecânica, elétrica, de processos, de sistemas, de software ou de pesquisa, a BD oferece recursos e a liberdade para inovar, com expectativas claras, responsabilidade por resultados e oportunidades de crescer sua carreira ao lado de tecnologia líder do setor.

E como uma das maiores empresas de tecnologia médica do mundo, você moldará soluções que alcançam sistemas de saúde globais e melhoram vidas em larga escala.

We are the people who give possibilities purpose

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

Responsibilities:

Lead and support failure investigations, root cause analysis, and problem-solving activities for non-conforming products and manufacturing processes.
Review and approve new or modified design and process specifications, including product performance requirements, test methods, and process validation documentation.
Contribute to and support the successful execution of quality engineering programs and project initiatives.
Independently analyze issues and develop effective solutions to complex quality and process challenges.
Provide guidance and direction to team members as needed.
Partner closely with manufacturing sites to address quality concerns and drive continuous improvement.
Serve as a quality engineering representative on cross-functional teams.
Define and maintain product control strategies to ensure consistent product quality and compliance.
Lead risk management activities throughout the product lifecycle.
Ensure compliance with design control requirements and regulatory expectations.
Plan, execute, and support process validation activities.
Support supplier qualification efforts, including risk classification assessments and product quality evaluations.
Assess and improve test methods used in product and process development projects.
Evaluate customer requirements to determine applicable quality and regulatory standards.
Review and approve the release of customer samples during product development activities.
Conduct and participate in quality functional reviews.
Ensure adherence to global Pharmaceutical Systems procedures, standards, and Quality Engineering practices.
Provide support during internal audits, customer audits, and regulatory inspections, including the implementation of corrective actions.
Drive continuous improvement initiatives focused on product quality, customer satisfaction, and market competitiveness.
Support new customer onboarding activities, including pre-feasibility and feasibility assessments.
Provide technical expertise, problem-solving support, and remediation guidance to manufacturing sites to prevent or minimize quality issues.
Collaborate with customer-facing teams to address quality and product-related matters.
Assist with supplier and internal quality system audits to evaluate the effectiveness of the Quality Management System and compliance with Good Manufacturing Practices (GMP).

Required Qualifications:

BS degree in Engineering, or other scientific discipline and 5 years relevant experience (Medical Device/ Pharmaceutical) OR
Masters Degree in Engineering, or other scientific discipline and 3 years relevant experience (Medical Device/ Pharmaceutical)

Knowledge and Skills:

Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMP Knowledge of design control principles.
Good understanding of statistical methods for Quality Assurance General working knowledge of the six-sigma process methodology
Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management. Knowledge and experience in manufacturing
Excellent problem solving and analytical skills
Ability to handle multiple projects simultaneously in an unsupervised environment.
Ability to thoroughly evaluate, clearly understand and communicate all aspects of assigned project.

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
Potential Discretionary LTI 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

Adoption assistance
Backup day care and eldercare
Support for neurodivergent adults, children, and caregivers
Caregiving assistance for 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

Salary Range for Franklin Lakes, NJ: $ 110,200.00 - 176,400.00 USD Annual

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company 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, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$110,200.00 - $176,400.00 USD Annual

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Perfil de Sucesso

O que diferencia profissionais de Engenharia e P&D bem-sucedidos? Você provavelmente se destacará se demonstrar:

Capacidade Analítica
Colaboração
Curiosidade
Atenção aos detalhes
Inovação
Solução de problemas

Pronto(a) para seu próximo desafio?

Este é um ambiente para engenheiros que querem pensar de forma ousada e executar com precisão. Você terá a oportunidade de influenciar decisões de design, contribuir em todo o ciclo de vida do produto e ver como seu trabalho avança do conceito ao impacto no mundo real, apoiado por uma líder global em MedTech.

Ouça um de nossos Inovadores BD sobre como a BD usa IA e machine learning de ponta para impulsionar decisões que melhoram os resultados dos pacientes e expandem o acesso ao cuidado. É aqui que seu trabalho gera impacto em tempo real em todo o mundo.

Um ambiente de trabalho feito para as pessoa

"A BD é uma empresa grande e global, então não tenha medo de se conectar e entrar em contato com outras pessoas. Há tanto para aprender aqui, e a empresa faz um trabalho incrível ajudando as pessoas a se desenvolverem e crescerem. Eu também sugeriria que você se tornasse como uma esponja e absorvesse o máximo de conhecimento possível e colocasse seu Career Blueprint (a ferramenta de plano de carreira da BD) para trabalhar a seu favor. Eu realmente amo meu trabalho e sou muito grata por trabalhar na BD."

Elaheh Alizadeh

Diretora, P&D – San Diego, CA, Estados Unidos
"Acho que temos mais de 30 países diferentes representados por aqueles que trabalham no Centro de Pesquisa da Irlanda, o que é impressionante e uma das minhas coisas favoritas sobre a BD. Trabalho com engenheiros elétricos, mecânicos, cientistas e muitos outros. É maravilhoso ver e ouvir tantas perspectivas diferentes durante o dia."

Balaguru Palanivel

Engenheiro de Teste de Software Sênior – Limerick, Irlanda
"Continuo impressionado com a forma como continuamos inovando no espaço MedTech. Constantemente avaliamos como trazer ainda mais soluções aos profissionais de saúde, como aumentar a eficiência de nossas tecnologias, tudo isso mantendo o impacto no paciente em mente. Não apenas encontrei um trabalho significativo na BD, mas um lugar onde sinto que posso prosperar."

Rob Swanda

Engenheiro Sênior – San Diego, CA, Estados Unidos
"Durante minha entrevista, descobri o quanto de impacto nossas soluções de infusão têm em todo o mundo e fiquei impressionado porque, seja para analgésicos, tratamentos de câncer, anestesia ou outros tratamentos, a probabilidade de alguém dentro da sua própria família usar nosso produto é alta. Contribuir para a criação de produtos que têm a capacidade de causar um impacto tão grande na saúde é uma sensação ótima. Adoro meu papel na BD."

Simon Bello

Diretor Sênior, P&D – San Diego, CA, Estados Unidos