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The Engineering manager will lead a Product Development team comprising of project engineers and product managers. The Engineering Manager will be responsible for the planning, managing, and supporting all product development projects within their team. This encompasses both sustaining and new product development initiatives.
Duties & 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 (procedures, validations, marketing materials, etc.)
Lead and develop new engineering and product development procedures or forms to improve department efficiency
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 (COGS, Gross Margin, etc.)
Oversee Product Development workshop, maintenance, and equipment
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 including product design, project management, manufacturing, and marketing
Participate in the development and review of risk management documents such as failure modes and effects analysis (FMEA)
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 (CAPA)
Support regulatory and reimbursement submissions for new products
Patent new technologies and processes
Conduct interviews, performance reviews, monitor annuals 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 guidance’s 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 works shift to complete assigned responsibilities and duties
Travel domestically and internationally up to 15% to attend offsite meetings, conferences, and support business initiatives
Skills And Abilities
Strong verbal and written communication skills, including presentation skills
Strong technical writing ability
Ability to manage a cross functional team
Knowledge of cleanroom manufacturing environments and validation procedures
Strong analytical and creative thinking skills
Ability to work in a fast-paced environment
Ability to secure and maintain a favorable background investigation and clearance
Education & Experience
Bachelor’s or master’s degree in biomedical engineering, tissue engineering, mechanical engineering, or related field required
10+ years of product development experience required
2+ years of experience managing engineering or product development teams required
Experience in mechanical design and 3D modeling required
Experience in manufacturing process design required
Experience with 21 CFR 820.30 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
Seniority level
Director
Employment type
Full-time
Job function
Engineering and Information Technology
Industries
Biotechnology Research
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