Manufacturing Engineer

Job Title

Pay Range: $48.24hr - $53.24hr

Requirement/Must Have:

• 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, with the ability to work with other engineers to influence product design to improve reliability.
• Troubleshooting mind set with 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 and participate in initiatives focused on yield improvement, material cost reduction, capacity enhancement, and outsourcing of assemblies.
• 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 regular analysis of factory data to anticipate and solve manufacturing/quality problems.
• Deliver improvements in yield, reliability, serviceability, manufacturability, testability, capacity and cost.

Nice To Have:

• 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.

Skills:

• Electro-mechanical Engineering.
• Process Engineering.
• Failure Analysis.
• Continuous Improvement.
• Troubleshooting.
• Design for Manufacturability (DFM).
• BOM Management.
• Medical Device Quality Systems.
• Yield Improvement.
• Budget Estimation.
• Strong verbal and written communication skills.
• Excellent communication and presentation skills.

Qualification And Education:

• BS degree in Mechanical Engineering, Biomedical Engineering, or equivalent.