Product Development Manager

4 days ago


San Antonio, Texas, United States Extremity Care Full time
Job Title: Engineering ManagerJob Summary:

Extremity Care is seeking an experienced Engineering Manager to lead our Product Development team. The successful candidate will be responsible for planning, managing, and supporting all product development projects within the team.

Key Responsibilities:
  • Develop and execute product development and product management strategies in alignment with business objectives.
  • Oversee product development projects for compliance with quality and regulatory requirements.
  • Communicate product strategies, updates, and performance metrics to leadership.
  • Develop and manage budgets for product development.
  • Conduct market research to identify product opportunities and market trends.
  • Identify and mitigate potential risks associated with product development.
  • Author, review, and approve product development and product management documents.
  • Support the development of validation, verification, and qualification protocols for compliance with regulatory requirements and project objectives.
  • Review and approve validation, verification, and qualification plans, protocols, execution data, and summary assessments for completeness and compliance with regulatory requirements.
  • Review and approve project plans to ensure alignment with the business, marketing, sales, and user needs.
  • Provide oversight, support, and approval of project timelines for accuracy and accountability.
  • Oversee product design development for effective solutions and scalable manufacturing processes.
  • Oversee and support technology transfer of new and licensed technologies.
  • Oversee and support the development of new product financials.
  • Conduct group trainings for direct reports to provide education on regulatory requirements, design controls, validations, product development, project management, and quality practices/processes.
  • Provide technical expertise and guidance to the Product Development team on varied product development aspects.
  • Participate in the development and review of risk management documents such as failure modes and effects analysis.
  • Collaborate with the Research Department to ensure product development objectives are met.
  • Collaborate with the QA & RA Departments to develop quality supplier agreements, labeling, product claims, 510k submissions, regulatory strategies, and sales & marketing materials.
  • Assist with investigation of product quality events and corrective and preventive actions.
  • Support regulatory and reimbursement submissions.
  • Patent new technologies and processes.
  • Conduct interviews, performance reviews, monitor annual goals, and establish performance improvement plans as needed.
  • Manage direct reports, work schedules, and timesheets.
  • Maintain a working knowledge of ASTM, AAMI, ISO, and other necessary validations or testing guidelines required for product development projects.
  • Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, and other regulatory requirements, if applicable.
  • Report to work in-person and start job duties on time for established shift.
  • Complete required hours on assigned work shift to complete assigned responsibilities and duties.
Requirements:
  • Bachelor's or master's degree in biomedical engineering, tissue engineering, mechanical engineering, or related field required.
  • Years of product development experience required.
  • 3+ years of leadership and management experience preferred.
  • Experience in mechanical design and 3D modeling required.
  • Experience in manufacturing process design required.
  • Experience with 21 CFR Design Controls required.
  • Proficiency in project management required.
  • Experience with allografts and/or medical devices required.
  • Experience in conducting/overseeing process validations, sterilization validations, and/or equipment validations.
What We Offer:

Extremity Care offers a competitive salary and benefits package, as well as opportunities for professional growth and development.



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