Senior Quality Engineer - Product Development

Regulatory Jobs; Tempe (AZ); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Career development opportunities

Job summary

BD is seeking a seasoned Quality/Engineering professional to support product leadership and risk management for new product development and sustaining activities for combination products. You will influence manufacturability, scalability, transfer, and post-launch sustainability.

Education includes a BS in Engineering with at least five years in medical device or pharmaceutical engineering. Travel up to 25% may be required as projects evolve.

Qualifications

• BS in Engineering
• Minimum of five years’ experience in engineering or Quality engineering within the medical device, pharmaceutical, or equivalent industry
• Pharmaceutical or combination product experience preferred

Responsibilities

• Provide technical leadership in medical device operations and QA
• Lead risk assessments and test methods development
• Lead component qualifications, design validation/verification and process validation
• Lead product investigations and risk-based decision making
• Translate design inputs into manufacturing control plans
• Support regulatory submissions and compliance with ISO 13485, ISO 14971, 21 CFR 210/211/820
• Coordinate product development activities and participate in project planning and audits

Skills

Risk management

Quality engineering

Process validation

Statistical methods

Regulatory knowledge

Cross-functional leadership

Documentation skills

Root cause analysis

Education

BS in Engineering

Job description

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

Job Summary:

This position supports product leadership and risk management of new product development and sustaining activities for combination products. The role may include aspects of manufacturability, scalability, manufacturing transfer and post launch sustainability of combination products.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

Job Responsibilities:

• Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance)
• Leads development of risk assessments and test methods
• Leads component qualifications, design validation / verification and process validation
• Leads product investigations
• Ability to make and present risked based decisions
• Assess product changes against product design
• Supports translation of design inputs into manufacturing control plans
• Develop and implement procedures to comply with corporate and industry standards.
• Coordinates and/or directs all aspects of product development activity related to a product line
• Quality engineering representation on Product Development Teams to design, develop, and implement new products and processes for a medical device, translating intangible design inputs into tangible engineering specifications and test plans
• Quality engineering representation on Design Review Teams
• Prepare and present project updates and technical discussions
• Participate in project planning, budgeting, scheduling, and tracking
• Support internal and external supplier audits
• Provide support to the regulatory department in writing technical submissions
• Comply with company procedures and policies, government regulations
• Ability to travel for business, project, and issues approximately up to 25% of time.
• Other duties and projects, as assigned

Education and Experience:

• BS in Engineering
• Minimum of five years’ experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry
• Pharmaceutical or combination product experience preferred

Knowledge and Skills:

• Knows how products are used and impact the user(s) so that risk can be managed effectively
• Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
• Ability to lead creation of risk management files
• Ability to develop solutions with business impact
• Advanced statistical and risk assessment techniques
• Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies
• Ability to make and present risk-based decisions
• Strong interpersonal skills
• Ability to analyze and optimize manufacturing and quality systems Product, design & prototyping
• Ability to create and provide trainin
• Problem solving ability
• Ability to create, review and coordinate test protocols and reports
• Ability to generate engineering proposals
• Oral and written presentation skills
• Ability to Lead cross functional teams
• Understanding of regulatory requirements including ISO 13485, ISO 14971, 21 CFR 210/211/820
• Preferred Qualifications:
• Quality Engineering Certification (ASQ) or equivalent

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

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Primary Work Location

USA AZ - Tempe Headquarters