Job Description

About the job

Our client is seeking a Senior Design Engineer to join their dynamic team and contribute to their mission of advancing women's healthcare. Our client has strategically invested in both organic and inorganic product portfolio development, aiming to be a global leader in their industry. To support this growth, a strong and experienced R&D team is essential for creating, launching, and maintaining both new and existing products. This role is crucial in designing and developing innovative product solutions. The position will provide design leadership for new product development projects, as well as all sustaining engineering activities. Successful candidates will be reliable, collaborative team players with excellent multitasking, communication, and time management skills.

Duties and Responsibilities:

• Collaborate with marketing to translate customer requirements into actionable specifications.
• Lead the design of novel product concepts based on customer needs.
• Select appropriate materials for new designs based on functional requirements, including metals, polymers, polymer-metal blends, and manufacturing methods such as injection molding, stamping, extruding, machining, and 3D printing.
• Design and develop new products and associated assembly and manufacturing processes, from raw material processing to final device assembly. Provide technical leadership for all new product projects and sustaining R&D activities.
• Manage all technical stage/gate deliverables for new product development.
• Translate voice of customer needs into target product solutions, concepts, and new product proposals.
• Prototype and develop proof-of-concept designs, disease models, and test methods for simulated environments, and develop new product designs based on defined user needs.
• Execute a long-term strategy for evaluating new designs, materials, and processing methods for current and next-generation products.
• Collaborate with IP counsel to identify and implement product patent strategies.
• Generate and execute test methods to characterize designs and establish root causes of design, manufacturing, or material defects.
• Create and maintain product CAD, including assemblies, components, and detailed drawings.
• Observe clinical cases and participate in interviews with clinical experts to inform designs.
• Assist in managing and directing external research and development projects for broader insights.
• Lead and participate in design reviews, contributing to the continuous improvement of processes.
• Identify and support component and process vendors, enhancing supply chain effectiveness.
• Guide engineering and laboratory teams in prototyping, manufacturing, and testing, fostering a collaborative and growth-oriented environment.
• Assist in managing and directing outside research and development projects for broader insights.

Required Knowledge, Skills and Abilities:

• 10+ years of product design and development experience, including early-stage concept and technical feasibility in biomedical engineering and/or the medical device industry.
• In-depth knowledge and experience in disposable medical device design and manufacturing. Preference for experience with electromechanical design and regulations (60601).
• Proven track record of successful new product designs reaching commercialization in a regulated environment.
• Strong medical device concept development, prototyping, and testing experience.
• Strong medical device design and manufacturing knowledge and experience.
• Working knowledge of electrosurgical design and regulatory requirements.
• Proficiency in Solidworks.
• Effective verbal, presentation, and written communication skills.
• Medical device product launch experience.
• Ability to travel up to 15-20%.

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