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BD (Becton, Dickinson and Company) Quality Engineering Manager - EU MDR in Tempe, Arizona

Job Description Summary

This position supports the activities required to support EU-MDR submission of products, including product gap assessments, planning and remediation of gaps and management of assigned departmental personnel.

This position is a limited term assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through May 31, 2024.

Job Description

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

  • Support of EU-MDR submissions: coordinates and/or directs all Quality activities surrounding EU-MDR submission of products. Assesses priorities and makes assignments to direct reports to ensure project and company priorities are met

  • Works with cross-functional teams to remediate gaps related to EU-MDR requirements and meets all deliverables in line with division and business goals.

  • Project Management: creates, tracks and meets project schedules. Assists with creating strategic plans and budgets for EU-MDR and assesses priorities and makes assignments to direct reports to ensure project and company priorities are met. Coordinates with team members, internal and external suppliers, and outside professionals to ensure project output meet business needs as well as applicable regulatory requirements.

  • Design to Manufacturing Transfer: supports product updates in line with EU-MDR requirements while maintaining design intent and smooth transfer to manufacturing.

  • Documentation: Support teams by reviewing product development plans and participate in design reviews, review and approve technical documents and reports. Reviews, approves and coordinates execution of verification and validation protocols and reports. Develops and implements department and division procedures/policy.

  • Test Method Development & Validation supports the development and validation of clinically relevant test methods that adequately challenge product design and processes.

  • Testing: Supports verification and validation activities for products and processes in support of EU-MDR requirements.

  • Training: Actively participates in training and providing input to training of employees on division procedures and policies

  • Supervisory/mentoring/coaching: Mentor/coach Quality Engineers through Product Development/Improvement/Maintenance activities. Typically supervises/manages various members of a Quality department, conducting performance reviews, recommending salaries and promotions, training, interviewing and hiring decisions, and disciplinary actions. Identifies development needs and potentials of employees, and provides or recommends project assignments and training to increase expertise to meet current or future division needs

  • Fiscal: Creates, controls, manages a project budget (expense and capital expenditure). Create and critique engineering cost analysis. Reviews and analyzes costs to identify and implement cost improvements.

Other Responsibilities may include, however are not limited to:

  • Support Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.

  • Support/lead design and process root cause analysis and support non-conforming product and complaint investigations.

  • Develop and implement procedures to comply with corporate and industry standards

  • Ability to make and present risked based decisions

  • Prepare and present project updates and technical discussions

  • Complies with company procedures and policies, government regulations

  • Other duties and projects, as assigned

Required Education and/or Experience:

  • B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Exposure to Biomedical Engineering or Bioengineering is a plus.

  • Minimum of five years’ experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry

  • Minimum of three years’ experience in supervisory capacity

Required Qualifications:

  • Demonstrated knowledge of development, manufacturing and quality system requirements for medical devices or comparably regulated environment is required.

  • Ability to create and execute project plans and lead cross functional teams.

  • Excellent oral and written communication skills, with strong, demonstrated skills in communicating with all levels of technical and operating management.

  • Strong ability to analyze and use technical data and resources. Proficient in statistical analysis and related software.

  • Ability to 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

  • 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

  • Ability to create and provide training

  • Problem solving ability

  • Understanding of regulatory requirements including 21 CFR 210, 211, ICH Guidelines, ISO 13485, ISO 14971

Preferred Qualifications:

  • Quality Engineering Certification (ASQ) or equivalent

Physical Demands:

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

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.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

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Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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