Medical Device Engineering Senior Manager

Nissha Medical Technologies - Buffalo, NY

Full-time - Senior

Buffalo, NY

About the position

The Medical Device Engineering Senior Manager at Nissha Medical Technologies is a leadership role focused on integrating Nissha technologies into medical device product solutions. This position requires a strong engineering background, particularly in design and development, and emphasizes the importance of delivering high-quality outputs that meet customer expectations. The role involves managing complex relationships, mentoring junior staff, and ensuring compliance with industry standards and regulations.

Responsibilities

• Apply engineering principles and processes to develop integrated product solutions using Nissha technologies.
• Communicate technical information effectively to customers and Nissha management through routine reporting and project status reviews.
• Collaborate with various Nissha divisions, departments, and sites to deliver commercially viable solutions based on customer inputs.
• Execute Design Control in compliance with 21 CFR 820 and MDSAP ISO 13485 standards.
• Develop fundamental Design and Development deliverables in accordance with industry standards for product development.
• Manage complex manufacturing processes and supply chain structures.

Requirements

• Bachelor's degree in an Engineering Discipline (preferably Mechanical, Optics, Electrical, Biomedical, or Aeronautical).
• 5 to 8 years of design-related experience.
• Excellent communication skills, both verbal and written, for conveying technical information.
• Proven ability to coordinate and lead technical meetings with diverse participants.
• Strong problem-solving skills and experience in designing multicomponent mechanical/electrical/optical systems.
• Working knowledge of Dimensioning and Tolerancing to ASME Y14.5.
• Experience in engineering analysis including Mechanics of Materials, Strength of Materials, Static Analysis, Dynamics, and Mechanism Analysis.
• Advanced understanding of plastics and metals manufacturing processes for healthcare components.
• Expert knowledge of 21 CFR 820/ISO 13485 Design Controls.
• Proficient knowledge of process development and process validation.

Nice-to-haves

• Master's degree or higher in an engineering discipline.
• Experience in participation in pre-clinical studies and attendance to clinical cases.