Manager Medical Device Development Engineering

Job Description
Remote Work: No

Overview:
At Zebra, we extend the edge of possibility by shaping the future of work on the front line—reinventing how businesses run and moving society forward.

We are a community of changemakers, innovators and doers who come together to deliver a performance edge to the front line of business. We develop new technologies and create new solutions with partners to help organizations act with greater visibility, connectivity, and intelligence—delivering better experiences for workers and those they serve.

Being a part of Zebra means being seen, heard, valued, and respected as you define your path to a fulfilling career. Here, you’ll have opportunities to learn and lead at a leading company, and you can channel your skills towards causes that you and the Zebra community care about, locally, and globally.

Together, we’ve only begun to define the edge of what’s possible—for our people, our customers, and the world.

Temptime (now a Zebra Technologies business) is the leader in designing and manufacturing a time-temperature monitoring product portfolio that meets the strict specifications of the largest global health organizations’ vaccination programs. Our temperature sensing technology serves every global manufacturer that participates in these programs. Our products help to save lives and our culture is encouraging and collaborative.

In this role, you will oversee various stages of the manufacturing process, including chemical analysis, compounding, coating, in-process checks, and testing. Using your advanced mathematics skills, you will seek continuous improvement, from small corrections to significant projects. In addition, you will develop and enhance processing methods, procure equipment and materials, optimize efficiency, and minimize costs while adhering to ISO and cGMP standards. Additionally, you will support new product development initiatives.

This role is located on-site at Zebra’s Morris Plains facility in New Jersey.
Only candidates living within commutable distance to the facility will be considered.

Responsibilities:

• Conducts and oversees complex work with high importance to the organization.
• Manages a small team of Technicians
• Ensures proper training of new employees and cross-training of existing team member
• Plans and organizes work of team members
• Approves timesheets for non-exempt empoyees
• Performs performance evaluations
• Develops, evaluates, and improves manufacturing processes using risk-based thinking to increase operational efficiency and enhance product quality
• Utilizes a variety of continuous improvement strategies (e.g. six sigma, lean manufacturing,
  statistical process control, etc.) in order to optimize the manufacturing process
• Supports manufacturing team by providing guidance, troubleshooting, and technical expertise to
  resolve process related problems
• Develops and generates productivity tracking metrics that accurately reflect manufacturing
  performance and production costs, allowing for data driven and economics-based decision
  making
• Interfaces with Quality Control and Quality Assurance to understand non-conformances and
  prevent recurring defects
• Communicates actively with Production Planning and Sales to ensure that on-time shipments are a
  top priority to Manufacturing, and that processing decisions are made accordingly
• Considers environmental protection and health and safety aspects of all process changes
  Prepares and presents internal company training material on continuous improvement concepts
• Works with outside vendors and contractors to determine product specifications, purchases
  equipment and materials, and evaluates products according to specifications tolerances and
  quality standards
• Participates, leads, and facilitates teams and meetings in a way that promotes participation and
  teamwork
• Effectively implements, maintains and adheres to all facility environmental, health, and safety
  policies and procedures
• Maintains work area organization and documentation to satisfy ISO and GMP standards
• Supports Research and Development activities, including participation in product/process
  development trials, introducing new types of raw material and product characterization/performance testing and use of experimental materials

Qualifications:
Minimum Qualifications:

• B.S. or M.S. in Engineering
• Preferred Disciplines: Biomedical, Chemical, Electrical, or Mechanical
• Alternatives: Industrial, Manufacturing, Petroleum, Systems, or other applicable discipline
• Minimum 8+ years total professional experience required.
• Experience supporting manufacturing operations required.
• Strong mathematical & numeracy skills required.
• Working knowledge of ISO 9001 required.
• Excellent communication skills and ability to effectively manage key stakeholders required.

Preferred Qualifications:

• Requires a high degree of critical thinking and risk assessment in a fast-paced work environment with frequently evolving focus and priorities.
• Specific technologies and industries preferred:
  • Printing, coating, or converting of high value materials
  • Pharmaceutical or medical device manufacturing or packaging
  • Printed electronics or photovoltaics
  • Colorimetry or small-scale dimensional metrology
• Experience in a cGMP facility in an FDA regulated industry is preferred
• Past roles should involve direct responsibility for production line outputs and/or production line performance (process engineering, process development, technology transfer, etc.)
• Previous supervisory experience of Operators, Technicians, and/or Engineers preferred
• Demonstrated ability to balance competing priorities including:
  • Medium and long-term process improvement to drive Overall Equipment Effectiveness (OEE) and maintain schedule adherence
  • Appropriately reacting to and resolving regulatory or compliance issues, and participating in regulatory or customer audits
  • Facilitating new product development efforts
• Certifications through ASQ or similar organizations are preferred (CSSGB, CSSBB, CQE, CRE, CQPA, CRE, etc.)
• Must be proficient at writing technical reports that include detailed statistical analysis, data visualizations, quantitative risk-assessment (FMEA), complex mathematics (e.g. modeling, multiple regression, etc.), experimental design (DOE), or Statistical Process Control (SPC)

Zebra is an equal opportunity/affirmative action employer committed to a diverse and inclusive workplace All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, disability and protected veteran status or any other basis prohibited by law. If you are an individual with a disability and need assistance in applying for a position, please contact us at workplace.accommodations@zebra.com. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment.

Know Your Rights:

https://www.eeoc.gov/sites/default/files/2022-10/EEOC_KnowYourRights_screen_reader_10_20.pdf

Conozca sus Derechos:

https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRightsSp_10_20.pdf

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Zebra is a federal contractor and is committed to an alcohol and drug free workplace. As a result, all U.S. based employees are subject to the Drug and Alcohol Free Workplace Policy and Procedure.

Zebra Total Rewards includes more than just pay and is structured to meet the needs of our changing global business and evolving talent. We are committed to providing our employees with a benefits program that is comprehensive and competitive – including healthcare, wellness, inclusion networks, and continued learning and development offerings. We offer community service days, in addition to the traditional insurances, compensation, parental leave, employee assistance program and paid time off offerings depending on the country where you work.

Salary: USD 117700.00 – USD 176500.00 Yearly

Salary offered will vary depending on your location, job-related skills, knowledge, and experience.
Additionally, all Zebra roles are eligible for cash incentive programs. For example, sales roles have additional opportunity to earn substantial variable compensation tied to quota achievement. In most other roles, the Zebra annual cash incentive program links Company and individual performance together. Some roles may also be eligible for long-term incentive equity awards.

To protect candidates from falling victim to online fraudulent activity involving fake job postings and employment offers, please be aware our recruiters will always connect with you via @zebra.com email accounts. Applications are only accepted through our applicant tracking system and only accept personal identifying information through that system. Our Talent Acquisition team will not ask for you to provide personal identifying information via e-mail or outside of the system. You can always verify the validity of a job posting or recruiter interaction by contacting us at HRServiceCenter@zebra.com If you are a victim of identity theft contact your local police department.