BD (Becton, Dickinson and Company) Associate Director - Reliability & Verification in San Diego, California

Job Description Summary

Job Description

Reporting to the Senior Director, MMS R&D Device Engineering, and the Associate Director (AD) Reliability & Verification drives design for reliability and design verification for MMS product development ensuring best practices are being followed. Accountable to ensure MMS internal and external development predictably yields objective evidence in meeting requirements andspecifications. This will be a newly created and centralized function with an expectation of raising the level of analysis and testing to ensure current and new products are meeting BD and regulatory levels of performance and reliability and ensure products meet requirements and specifications with quantitative evidence.

The AD R&V assures consistent and repeatable practice and application of reliability and verification practices across MMS internal and external partner testing sites. The AD R&V contributes to the strategic planning process by identifying and implementing needed capabilities, assessing resource and funding requirements, and implementing required changes to process and practice.

The AD R&V is accountable for the timely execution of reliability and verification activities in support of the MMS portfolio. This position involves the leadership and management of engineers and technicians and responsibility for the career development for these associates.

Living the BD Values and Cultural Priorities

  • We do what is right

  • Are authentic

  • Are all accountable

  • Improve every day

  • Help each other be great

  • Agile and results driven

  • Customer Centric and innovative

  • Inclusive and diverse

PRIMARY RESPONSIBILITIES

  • Create a new centralized design verification and reliability testing organization and raise the capabilities within R&D and Quality to ensure highly reliable and robust products are going to market and performing in the market.

  • Accountable for all FDA 820.30, and similar, design verification activities for the MMS global organization including both regulated and non-regulated products.

  • Formulate and drive strategy to assure consistency in practice and approach across design centers both internal and external.

  • Create and maintain best in class reliability and verification practices to assure the safety and efficacy of infusion and dispensing devices over their product lifecycle

  • Drive rigor and consistency to new designs and design changes to ensure products meet requirements and specifications through thorough testing.

  • Direct and oversee the development and maintenance of test and verification test beds and equipment to fulfill best in class practices.

  • Assure proper metrology, data collection and analysis practices are applied for all reliability and verification projects and activities.

  • Personnel management and development for engineers, technicians

  • Manage engineering labs and equipment

  • Manage department budget

  • Assure compliance with QSM, actively drive improvements

  • Drive best in class practices for design verification for embedded control systems

  • Work with PM’s & FM’s to assure resources are available to support programs

  • Continuous Improvement: Assess methods and practices and implement improvements routinely. Determine best split between internal and external testing

  • Provide critical technical review of work performed by department personnel to assure quality, completeness and compliance

POSITION “SPECIFIC” OVERVIEW

The Associate Director Reliability and Verification position is responsible for: 1) Assuring technical capability and functional excellence to fulfill 820.30 Design Verification and QMS requirements for products developed and extended/sustained within the MMS portfolio, 2) Assessing resource requirements, capacity and availability to support the MMS product roadmap, 3) Assuring alignment of project requirements with reliability and verification plans, 4) Resolving issues impeding timely project execution, 5) Monitoring and sponsoring the career development of associates within the R&V organization, 6) Proactive budget management to execute within available funding.

  • Establishes and leads business and functional and strategies / objectives.

  • Considered an expert in their functional knowledge and expertise to the business. Participates in a wide variety of business discussions and decisions for the development of new products, manufacturing strategies, and sustaining / post market activities.

  • Carries out Management responsibilities such as the hiring, job assignments, performance planning and talent development, salary actions, performance reviews, and termination recommendations.

  • Owns the R&V annual budget, assuring appropriate planning and funding to achieve objectives within approved budget.

  • Perform other related duties and assignments as required.

  • Excellent analytical, technical, and problem-solving skills (TQM or Six Sigmaexperience preferred).

  • Ability to perform multiple tasks / large projects and to prioritize workload for function.

  • Effectively / actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties

  • Ability to work in and to direct teams to obtain results.

  • Knowledge and experience in financial management, planning, and organizational skills.

  • Self-motivated/directed.

  • Excellent analytical, technical, and problem-solving skills (TQM or Six Sigmaexperience preferred).

  • SUPERVISION

  • Manages subordinate managers and/or experienced specialist employees who exercise significant latitude and independence

Minimum

  • 5+ years management in a related role in the medical device industry

  • Bachelor’s/Master’s degree in technical field; ME, EE, Biomed, Physics or other relevant subjects

  • Expertise in Reliability Engineering & Statistics

  • Expertise in Design Verification in an FDA 820.30 environment

  • Experience managing across multiple geographies (ideally)

  • Experience with test development and execution for electro-mechanical automated and semi-automated test stands

#LI-TECH

Primary Work LocationUSA CA - San Diego TC Bldg C&D

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