Team Lead Design Engineering

at  J Sterling Industries

ENGINEERING @ STERLING

The Team Lead of Design Engineering will oversee the design engineering team, guiding the development of innovative, cost-effective solutions for customers in a fast-paced contract manufacturing environment. This role requires strong leadership skills, technical expertise, and a deep understanding of design-for-manufacturing (DFM) principles. The team lead will collaborate with cross-functional teams including operations, quality, and manufacturing, ensuring that design outputs meet customer specifications, regulatory standards, and production goals.
This role will develop technical competencies of the team by providing direction, training, and continual mentorship, and will also be responsible for implementing and maintaining best in class design processes. This role will benefit someone who is open to collaboration and able to adapt to changing situations.

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• Lead and mentor a team of design engineers, ensuring timely delivery of design projects from concept to production.

• Provide technical oversight and guidance to ensure designs meet customer requirements, manufacturability, and quality standards.
• Review and approve design documentation, drawings, specifications, and engineering reports.
• Collaborate with project managers and manufacturing teams to align design activities with project timelines, budgets, and production capabilities.
• Facilitate communication between internal teams and external customers, ensuring all design changes, updates, and risks are clearly communicated and addressed.
• Drive continuous improvement initiatives, including the implementation of DFM, cost reduction strategies, and process optimizations.
• Support new product introductions (NPI), ensuring designs are optimized for scalability and manufacturability in a high-mix, low-volume production environment.
• Manage resource allocation within the design team to meet project and organizational needs.
• Ensure compliance with relevant industry standards and regulatory requirements, such as ISO, FDA, or other applicable standards.
• Work closely with suppliers and vendors to ensure design requirements are understood and met throughout the supply chain.
• Lead root cause analysis and corrective actions for design-related issues encountered in manufacturing or customer feedback.
• Foster a culture of innovation and collaboration within the team, promoting professional growth and skill development.
• Performs feasibility studies, cost analyses and simulations as required to assess the technical and economic viability of the concepts.
• Performs detailed design of mechanical enclosures, sub-components and wiring harnesses evolving them into a prototype or production ready product.
• Considers DFM/DFA in all areas with a view to creating a high volume, high yield product while maintaining reliability.
• Uses analysis and /or simulation, including SolidWorks Simulation and Flow Simulation to evaluate and optimize designs for thermal performance while balancing other criteria.
• Uses SolidWorks to prepare 3D models and component drawings while adhering to precedent and recognized methods.
• Creates tolerance stacks to determine product assembly.
• Assist in test procedures and executes them where necessary and is involved in failure analysis of field returns.
• Creating engineering documentation (models, drawings, specifications, documents, testing protocols, etc)
• Support quotations, sales and order management, assembly, and manufacturing departments efforts from a design, documentation and troubleshooting standpoint.
  Requirements and Education:
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• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or a related field with relevant design experience in medical device industry. Master’s degree is a plus.

• Must be experienced in using advanced CAD techniques with SolidWorks, SolidWorks Simulation, SolidWorks PDM including component modeling and detailed drawings.
• 7+ years of experience in design engineering, with at least 3 years in a leadership or team lead role. Experience in medical device design and development, preferably in a CM environment.
• Knowledge of materials science, manufacturing processes (injection molding, machining, automation, etc.), and rapid prototyping techniques.
• Proficient in 3D CAD software (e.g., SolidWorks, AutoCAD) and other relevant design tools.
• Familiarity with industry standards and regulatory requirements such as ISO 13485, FDA 21 CFR Part 820, etc.
• Strong knowledge of design-for-manufacturing (DFM) and design-for-assembly (DFA) principles.
• Excellent project management skills with the ability to prioritize tasks, manage multiple projects, and meet deadlines.
• Strong communication and interpersonal skills, with the ability to lead cross-functional teams and interact with customers.
• Proven ability to solve complex design problems and make data-driven decisions.
• Experience in leading design reviews, risk analysis (FMEA), and root cause investigations.
• Expert proficiency in SolidWorks/CAD, including drafting, Design for Manufacturing (DFM), Design for Assembly (DFA), and a proven understanding of GD&T 14.5Y, tolerance definitions, and tolerance stack-up analysis.
• Demonstrated ability to conceptualize, quote, and execute production-related tools and equipment.
• Experience in medical device design and development, particularly in a CM environment.
• Understands and practices a coaching and mentorship approach to employee development.
• Familiar with GD&T drawing practices.
• Knowledge of die-casting, metal forming and injection molding processes and their requirements.
• Knowledge of manufacturing processes and the associated requirements / constraints put on design.
• Good problem-solving skills and being able to think critically through concepts quickly in the initial concept stage.
• Strong written and oral communication skills in English.
• Tooling and machine / automation design experience is preferred.
• Experience in medical device design and development, preferably in a CM environment.