• Pfizer Canada
  • $111,680.00 -166,760.00/year*
  • Flemington , NJ
  • Engineering
  • Full-Time
  • 18 Brentwood Ct

ROLE SUMMARY

The Device Engineering Co-Development Director leads a global team that is responsible for support of Pfizer s New Product Introduction (NPI) activities for Medical Device and Combination Products. This position will provide strategic and technical leadership for launch readiness in cooperation with WRD BioTherapeutics, WRD PharmaTherapeutics and GPD Pharmaceutical Sciences in supporting the design transfer and site readiness assessment for all new products and for products transferring sites.

ROLE RESPONSIBILITIES

  • Develop and facilitate a co-development process for Medical Devices and Device Constituent parts of Combination products
  • Ensure appropriate knowledge management and transfer from R&D to production
  • Responsible for leading major design changes, including plastic injection molded components of devices
  • Sphere of control: process qualification and design validation through first year of launch
  • Shared responsibility between R&D and PGS for DHF / Changes 6 month post launch (R&D partner)
  • Oversight of DHF content / structure suitable for launch
  • Co-Lead new technology introduction with R&D
  • Co-Lead control strategy for production (definition for CQA / CPP)
  • Support technical audits of new / existing suppliers
  • Post marketing surveillance plan (PMS Plan) contributor
  • Responsible for changes that require clinical, human factors, or develop state of the art postmarket
  • Manage network-wide project prioritization for new product introduction
  • Coordinate tooling design and engineering Support for the entire lifecycle of custom injection molded components
  • Coordinate device engineering support for PAI audits at internal production sites and CMOs
  • Support submission preparation and regulatory strategy for combination product and medical device fillings
  • Liaison with R&D / Lifecycle Management / Launch Excellence Teams
  • BASIC QUALIFICATIONS

  • Bachelor s degree in Packaging, Mechanical, Chemical, Biomedical or related Engineering Science is required. Advanced degree desirable.
  • 15 years experience in Device Design, Quality Engineering, Pharmaceutical Package Engineering, Package Design or equivalent Technical Project Management preferred
  • 10 years experience in Medical Device and Combination Products Design Controls, Production, Sustaining Engineering role or related field preferred
  • Deep technical expertise in Design Control and Risk Management
  • Practical application of Design for Reliability and Manufacturing (DRM) and robust device design practices
  • Practical application of analyzing complex issues for patient/user impact
  • Experience with FDA investigators and other global regulatory agencies
  • Thorough understanding and in-depth knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and related standards
  • Deep technical expertise in production and production systems in a GMP regulated environment
  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
  • PREFERRED QUALIFICATIONS

  • Deep technical expertise in device design, development, qualification and registration
  • Proven project management and complex problem solving skills
  • Ability to effectively manage and influence global cross functional teams
  • Excellent relationship management, communication and presentation skills
  • Excellent verbal, written and interpersonal communication skills
  • Demonstrated ability to plan, implement, and achieve significant, complex goals and objectives
  • Demonstrated leadership with proven success in challenging status quo
  • Strong organizational and planning skills, as well as a high energy level and initiative
  • PHYSICAL/MENTAL REQUIREMENTS

    Office-based role supporting virtual teams via webex and phone. Flexibility required when working with global colleagues in various time zones.

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

    Must be able to travel up to 30%

    Sunshine Act

    Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

    EEO & Employment Eligibility

    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

  • Last Date to Apply for Job: 7/22/2019
  • Additional Location Information: Position can be located in any Pfizer Global Site
  • Eligible for Relocation Package
  • Eligible for Employee Referral Bonus
  • #LI-PFE

    N (Other) (United States of America)

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


    Associated topics: bio, biomaterials, biomedical, bioprocess, biosynthetic, hereditary, medical, neurodegenerative, nutrition, pain

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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