Senior Project Engineer - Acute Care

Overview of the Role

The Senior Project Engineer is responsible for planning and coordinating engineering initiatives to support existing products and new product development. This includes researching regulations, developing project implementation plans, generating specifications, and managing allocated resources to ensure project success.

Duties and Responsibilities

• Author and maintain project documentation, including project plans, SOPs, work instructions, and Design History Files (DHF).
• Author regulatory clearance submissions (FDA 510(k), CE Mark, etc.) ensuring minimum requirements are met.
• Contribute to IP strategy, work with patent attorneys to identify and protect novel innovations.
• Research regulations and ensure compliance with FDA design control requirements.
• Support project launches and implementation of post-market design improvements.
• Identify and resolve production scale-up challenges; transition designs from development to manufacturing and commercialization.
• Conduct process and equipment validation activities; support packaging and labeling validations.
• Engage clinicians to identify unmet needs through direct clinical observation in the hospital environment (operating room, ICU, etc.).
• Assist with supplier qualification, audits, and quality performance feedback.
• Continuously improve quality systems, processes, documentation and assist with quality audits.

Qualifications

• A bachelor’s degree in mechanical or biomedical engineering is required.
• Minimum of 8 years of mechanical and/or technical experience working in the medical device field.
• Proficiency in CAD software for design and drafting (SolidWorks).
• Ability to plan, organize, and execute complex projects within a timeline and a budget.
• Excellent problem-solving skills with experience in root cause analysis and risk management.
• Strong communication skills, interacting effectively with clinicians, management, and cross-functional teams.
• Strong knowledge of FDA regulations, ISO 13485, and medical device quality systems.