Senior Manufacturing Engineer

Senior Manufacturing Engineer

Requirements

• Candidate must be of high character and energy with regard for detail.
• Demonstrated Electro-mechanical and/or Process Engineering ability.
• Demonstrated ability in failure analysis and continuous improvement.
• “Self-starter” attitude and comfort in a hands-on environment, where he/she can demonstrate an ability to work with other engineers to influence product design to improve reliability.
• Troubleshooting mind set – an ability to systematically and effectively break down a system or process into subparts to identify failures and troubleshoot to component level.
• Excellent documentation skills and ability to communicate effectively both verbally and in writing across all levels of the organization.
• BS degree in Mechanical Engineering, Biomedical Engineering, or equivalent.
• 3-5 years relevant work experience.

Responsibilities

• Duplicate, qualify, and scale surgical robotic systems manufacturing lines in the new facility.
• Provide product and process Design for Manufacturability input to enhance manufacturability and servicing.
• Take ownership of products from production phase through end-of-life.
• Assist in creation and maintenance of efficient “mid-volume” manufacturing assembly line, specifying and/or refining BOMs, workflow processes and detailed work instructions.
• Provide training and support to production technicians.
• Design, qualify, document, and introduce production and service assembly/test fixtures & equipment.
• Maintain compliance with medical device quality system including corrective action closure, discrepant material dispositions, and change implementation.
• Provide technical support analyzing and/or perform failure analysis for discrepant production components, assemblies, and field returns.
• Lead/participate in initiatives focused on yield improvement, material cost reduction, capacity enhancement, and outsourcing of assemblies.
• Must possess excellent communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support, and clinical marketing organizations.
• Manage and allocate team resources over multiple projects. Negotiate for needed resources from other teams to enable project success as needed.
• Create budget estimates for tooling, test equipment, prototype designs, and first article activities. Assist material procurement and supplier quality teams with development and maintenance of contract manufacturers for mechanical assembly.
• Perform other duties as required.

Preferred Qualifications

• MS degree in an Engineering discipline.
• 5-7 years relevant work experience as a design or manufacturing engineer supporting product with significant mechanical content.
• Prior experience with various sensor applications and technologies, including reliability and performance assessment.
• Prior experience working in an FDA/ISO regulated environment.
• Demonstrated ability to effectively design experiments.
• Prior project leadership experience.
• Prior supplier quality responsibility.