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    Director, Medical Device Development And Manufacturing

    Sun Pharma
    15+ years
    Not Disclosed
    Billerica
    10 Nov. 28, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: Manager, Technical Engineering (Combination Products)
    Company: Not specified
    Location: Not specified

    Job Summary

    The Manager, Technical Engineering will lead a team of engineers and serve as a subject matter expert (SME) in the development of combination products. The role involves guiding the team through the phases of product identification, feasibility, development, qualification, and launch readiness. Responsibilities include ensuring compliance with regulatory requirements such as FDA Part 4, Part 210/211, Part 820, ISO 13485, and Canadian Medical Devices Regulations (CMDR SOR/98-282), among others. The manager will lead cross-functional teams, collaborate with internal and external stakeholders, and ensure quality management system (QMS) compliance.

    Key Responsibilities

    • Team Leadership:
      • Provide functional leadership to technical device teams and external consultants.
      • Ensure the team meets standards for Design Control and Design History File (DHF) requirements in compliance with regulations.
    • Project & Technical Leadership:
      • Oversee projects through clinical development, product registration, and launch-readiness.
      • Ensure execution of projects in compliance with Design Control SOPs.
      • Provide guidance for design verification protocols, design validation activities, and Human Factors studies.
    • Collaboration with External Partners:
      • Build strong relationships with external design/development partners, manufacturing partners, and service providers.
      • Support optimization of design control elements to comply with medical device regulations.
    • Regulatory Compliance:
      • Lead or assist in investigations of deviations, complaints, and failure analyses.
      • Author or revise SOPs related to medical devices and associated systems in alignment with regulatory guidelines and corporate policies.
    • Other Duties:
      • Perform additional tasks as required related to technical leadership and project execution.

    Work Conditions

    • Office Environment
    • Device Development Laboratory
    • Manufacturing Floor/ Warehouse
    • Third-party sites (as required)

    Physical Requirements

    • Ability to stand, sit, walk, stoop, kneel, reach, and climb as required.
    • Ability to lift up to 25 lbs.
    • Close vision and ability to use computer/office machines.
    • Must wear personal protective equipment (PPE) (gloves, lab coat, safety glasses, etc.) as required.

    Education and Job Qualifications

    • Education:
      • Bachelor’s degree in Engineering (required).
      • Master’s degree in Engineering (preferred).
    • Experience:
      • Minimum 8 years of cross-functional leadership in medical device or combination product development.
      • 15+ years of experience in medical device/combo product development and commercialization.
      • Proven track record of regulatory approvals for drug delivery systems (preferred).
    • Skills:
      • Extensive knowledge of engineering principles and industry standards (ISO, AAMI, ANSI, etc.).
      • Strong technical leadership skills with a proven history of delivering products to market.
      • Expertise in project management and experience working with external partners (testing labs, CROs, CMOs).
      • Excellent written and verbal communication skills, including experience presenting to multidisciplinary teams.
      • Strong collaboration skills with Quality, Manufacturing, Regulatory, R&D, Clinical, and other stakeholders.

    Experience

    • Experience with Design Control (21 CFR 820), ISO 13485, ISO 14791 requirements.
    • Experience interacting with external design, development, and manufacturing partners.
    • Strong project management skills and an aptitude for contingency planning.

    Compensation and Benefits

    Compensation details are not specified, but this role is likely to include benefits in line with leadership positions in the medical device field, including health insurance, retirement plans, and paid time off.

    Disclaimer

    This job description provides a general overview of the responsibilities and qualifications for this position but may be subject to change based on the employer's needs or the incumbent's background.

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