Director of Engineering, Medical Business

About ENNOVI

From automotive and aerospace to consumer electronics, data storage, industrial, and medical markets, we help our customers create smarter, safer, and more sustainable solutions.

We thrive best in developing high-performance custom solutions that meet diverse technical needs, solve unique challenges, optimize performance, and adapt to evolving market demands.

Our mission is to get customers to the future faster, from anywhere. Headquartered in Singapore, ENNOVI has a global presence across North America, Europe, SEA and China, where all its activities are socially responsible, with minimal environmental impact. Learn more at www.ennovi.com.

Ennovi is an equal opportunity employer in conformance with all applicable laws and regulations to individuals who are qualified to perform job requirements. The Company administers its personnel policies, programs, and practices in a non-discriminatory manner in all aspects of the employment relationship, including recruitment, hiring, work assignment, promotion, transfer, termination, wage and salary administration, and selection for training.

Why Join Us

At Ennovi, we envision a future of electrification and innovation and strive to create an inspiring workplace where our employees are integral to shaping that future. We offer a dynamic, collaborative and inclusive culture that encourages continuous learning, professional growth, and a sense of purpose. As a part of the Ennovi team, employees experience the excitement of being at the forefront of cutting-edge technologies and contributing to a sustainable future.

Our commitment to the transformation is epitomized by our five pillars: Speed, Innovation, Best Talent, Global Reach, and Sustainability. This entails navigating exponential market changes through agile structures, fostering innovation across all aspects of our business, strategically expanding our global footprint, championing sustainability initiatives and nurturing a winning team.

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About the Medical Business

Ennovi Medical

is the medical-focused division within

ENNOVI

, created as part of the company’s strategic expansion “Beyond Automotive,” which brought

Interplex Medical

under the ENNOVI brand. The division delivers

precision, scalable, and highly reliable medical solutions

that enable OEMs to develop

mission-critical smart medical devices

. These solutions support applications such as

diagnostics, continuous glucose monitoring (CGM), and minimally invasive surgical technologies

Core Capabilities

Ennovi Medical leverages ENNOVI’s deep expertise in

mechanical and electrical interconnect systems

to provide customized components and assemblies specifically engineered for medical applications. These capabilities support high-performance devices requiring robust connectivity, miniaturization, and precision manufacturing.

Learn more at www.ennovi.com/medical/

Position Summary

The Director of Engineering is a key leadership role responsible for driving the strategic and operational excellence of engineering within ENNOVI Medical. This leader oversees product development, engineering operations, process engineering, and cross-functional technical teams to deliver innovative, compliant, and manufacturable medical technologies. The Director ensures that engineering output meets regulatory requirements, customer expectations, and company growth objectives while cultivating a culture of technical rigor, operational discipline, and continuous improvement.

Key Responsibilities

Leadership \& Strategy

• Lead and develop a high-performing engineering organization, including product development, R\&D, systems engineering, manufacturing engineering, process development, and sustaining engineering teams.
• Establish the long-term engineering roadmap aligned with business strategy, customer needs, and industry trends.
• Drive innovation while ensuring designs are efficient, scalable, robust, and manufacturable for high-quality production.
• Serve as a key member of the leadership team, providing technical guidance and strategic insight for business development, operations, and quality initiatives.

Product Development \& Technical Oversight

• Oversee full lifecycle product development—from concept and feasibility through design transfer, validation, and commercial launch—within FDA and ISO-regulated environments (e.g., ISO 13485, 21 CFR Part 820).
• Ensure effective application of design controls, risk management (ISO 14971), verification/validation, and documentation requirements.
• Provide technical guidance on complex engineering challenges, including mechanical design, electronics, software, materials, and system integration.
• Partner with customers to define requirements, manage technical communication, and ensure successful execution of project deliverables.

Operational Excellence \& Manufacturing Support

• Drive robust process development, DFM/DFA, and design transfer to manufacturing, enabling efficient, scalable production.
• Collaborate closely with Operations, Quality, Supply Chain, and Program Management to ensure engineering decisions support cost, quality, and delivery goals.
• Champion continuous improvement initiatives (Lean, Six Sigma, automation, digital tools) to enhance operational efficiency and product performance.

Regulatory, Quality \& Compliance

• Maintain engineering compliance with applicable medical device regulations and standards, including ISO 13485, ISO 14971, IEC 60601, and FDA QSR.
• Support audits, technical documentation, and regulatory submissions (510(k), PMA, CE marking, etc.) in collaboration with Quality and Regulatory teams.
• Ensure design history files, technical files, and engineering documentation meet internal and external requirements.

Project \& Resource Management

• Oversee engineering program budgets, staffing plans, schedules, and resource allocation across multiple concurrent projects.
• Ensure strong project management discipline, technical risk mitigation, and milestone achievement.
• Evaluate and approve engineering tools, equipment, infrastructure, and technology investments.

Qualifications

Required

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related field.
• 10\+ years of engineering experience in the medical device industry, including significant leadership responsibilities.
• Proven track record leading multidisciplinary engineering teams in a regulated product development environment.
• Strong understanding of design controls, product development processes, quality systems, and medical device regulatory requirements.
• Demonstrated experience with contract design or contract manufacturing environments (CDMO/CMO).
• Excellent communication, leadership, and decision-making skills.

Preferred

• Master’s degree or advanced technical degree.
• Experience with Class II or Class III medical device development.
• Familiarity with electromechanical and software-driven medical systems.
• Training or certifications in Lean, Six Sigma, or project management (PMP).

Success Traits

• Strategic thinker with a hands-on leadership style.
• Strong technical depth combined with exceptional organizational and executional skills.
• Customer-oriented mindset with the ability to manage diverse technical and business priorities.
• Motivational leader who fosters innovation, collaboration, and accountability.

Preferred Location:

• Attleboro, MA or Tamarac, FL