Purpose:

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.).
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.).
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
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.

Skills & 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.
8 - 10+ 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 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

RegenTX, LLC jobs

Engineering Manager - Medical Device/Tissue