Quality Director for Medical Devices - Carlsbad, CA, United States - Enovis

Description

The Director Engineering, New Product Development (NPD)'s primary responsibility is to manage a team of engineers, drafters, and machinists and drive technical activities of one or more engineering functions.

Engineering functions may include mechanical, hardware, software, electronics design, development, and quality assurance.

Technical activities include designing, machining, prototyping, drafting, voice of customer (VOC), risk management, coordinating and executing verification and validation testing, design transfer, and ensuring design rigor consistent with Medical Device standards.

Additionally, the manager will be responsible for managing, mentoring, coaching, and motivating managers as well as junior engineers.

The candidate must have a proven track record of launching medical devices to the market, preferably in the orthopedic market.

The Director Engineering will also play an active role in BAS' annual and multi-year strategic initiatives such as planning opportunities for new organic growth, evaluation of acquisitions, and large-scale business process improvement activities using lean methodologies.

Manage a team of mechanical, hardware, software, electronics engineers and other technical resources, who support new product development projects for Bracing and Supports
Manage NPD projects activities from feasibility phase through final product launch, in collaboration with cross-functional management teams and the Bracing and Supports leadership team
Manage a team of technical personnel who provide support for the existing Recovery Sciences products
Coordinate with the global cross functional teams and manufacturing sites to prioritize and execute projects
ensure the team builds detailed plans, schedules, budgets, and appropriate risk mitigation
Overseeing the design of parts, engines, tools, and other mechanical equipment
Experience in Mechanical Eng. & Design, Modelling (SolidWorks), Industrial Design, Product/ Mechanical Testing, Soft-goods / Sewing, Drafting/ GD&T, Oracle Configuration, Injection Molding, Sheet Metal, Machining
Develop in collaboration with other departments the entire project documentation (DHF), Engineering Change Orders (ECO), and Device Master Record (DMR) updates following approved procedures
Develop strategies for Bracing and Supports, including requirements for new product development, determination of new skills or capabilities, and identification of acquisition targets
Work with cross functional leaders to improve the New Product Development process

Develop competency in the most relevant EGX tools, including Accelerated Product Development, Root Cause Countermeasure, and Transactional Process Improvement.

Bachelor's or Master's degree in Engineering, Product Design, Business Administration, or related field. Proven experience years) in a senior product development role, preferably in medical device
~5-10 years management experience
~ Experience with medical device product development

Excellent project management abilities, including budgeting and resource allocation.
Experience in embedded systems (mixed design, mechanical, electronics, software)
Provide leadership, guidance, and mentorship to the product development team, fostering a high-performance culture and encouraging professional growth.
Pursues training and development opportunities. Expresses ideas clearly and simply both verbally and in writing. Ability to take direction from multiple sources and manage conflicting priorities in an effective and efficient manner. Ability to multi-task, completing concurrent projects within given time frames and managing interruptions and change requests. Decision Making – Makes timely, sound decisions based on analysis, wisdom, experience, and judgment. Teamwork – Builds high performing teams and interacts productively with commercial partners. Possess and demonstrate the ability to form strong partnerships with cross-functional partners and transfer these understandings.
Assists in building cohesive teams, bringing out the best from peers while fostering teamwork and collaboration.
Managing Others – May be responsible for direct reports and accomplishing work through outside resources. Demonstrates change management skills. Demonstrated strengths in organization development, planning and communication. Takes timely action to address performance issues.

Resource Allocation and Budgeting – Manage resources effectively, allocate budgets, and make strategic decisions regarding resource allocation for various projects.

Risk Assessment and Mitigation – Identify potential risks and challenges in the product development process and develop strategies to mitigate them.

Performance Tracking and Reporting – Establish KPIs, track project performance, and provide regular reports to senior management on the progress of new product initiatives.

Compliance and Quality Assurance – Ensure that all new products comply with industry standards, regulations, and quality requirements.
Achieves objectives across varied international conditions. Effectively leverages local skills.

Project Management – Ability to plan, organize and manage resources to bring about the successful completion of specific project goals and objectives.

Computer Skills – Proficient computer system-based tools including Microsoft Office applications, presentation, project planning, flow charts, e-mail, web browsers and spreadsheet software.

Travel
Work occasionally in an engineering lab and visit manufacturing sites
Enovis Corporation (


NYSE:
ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.

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