Manufacturing Engineer

Primary Function of Position

Contribute your technical manufacturing, equipment design and project management skills to a

dynamic manufacturing engineering team creating precision instruments for minimally invasive

robotic surgery.

The role requires active participation in a manufacturing engineering organization in order to

refine electro-mechanical components, assemblies, process documentation, tooling and test

methods to improve efficacy, reliability, manufacturability and cost for surgical robotic

instruments.

Essential Job Duties

 Contribute to a collaborative team, which is focused on continuous improvement

 Employ Design for Manufacturing/Assembly (DFx) to

develop optimal product architecture in terms of reliability,

quality, and cost.

 Specify, design, document, and procure the equipment

necessary to perform each process step.

 Plan, budget, and provide the production equipment necessary to meet manufacturing

capacity requirements.

 Define lean manufacturing process flows to maximize production efficiency.

 Author process FMEA’s to identify and address potential manufacturing defects and

minimize risks to patient safety.

 Validate manufacturing equipment and processes to ensure efficacy and compliance with

applicable requirements.

 Maintain and improve production quality, yield, cost, and capacity.

 Maintain compliance with medical device quality system including corrective action

closure, discrepant material disposition, and Engineering Change Order (ECO)

implementation.

 Evaluate and help in the selection of suppliers for mechanical parts if required.

 Help resolve supplier quality issues.

 Update and revise Manufacturing Process Instructions (MPIs) to ensure accuracy and

completeness

 Address line support issues as they arise; Document and report any variances, problems,

issues, or concerns on all aspects of the manufacturing process

 Provide production personnel with expectations and performance feedback regularly in

the production process

 Understand, train personnel, and enforce strict adherence to the applicable Department

Operating Procedures (DOPs) and Standard Operating Procedures (SOPs) of the Quality

System

 Maintain up-to-date and accessible training records for MPIs and Quality System

documents

 Assist in setting and attaining quarterly and annual production goals

 Learn and enforce company safety policies and practices

 Active participant in quality improvement initiatives, providing feedback to find the root

cause and problem-solving.

Required Skills and Experience

• Excellent organizational skills; able to manage multiple fast-paced assignments

simultaneously

• Ability to communicate effectively and professionally across a

range of technical disciplines and cultures with a broad slate of

stakeholders, including management, peers, customers, and

suppliers

• Ability to solve complex technical problems with equipment

and/or manufacturing processes

Required Education and Training

• B.S. degree in engineering discipline required
• M.S. degree in engineering discipline preferred

Working Conditions

None

Preferred Skills and Experience

 1-3 years of experience in NPI, manufacturing, or design engineering supporting Mid-high

volume complex mechanism manufacturing experience

 Knowledge of a wide range of manufacturing processes, such as machining, injection

molding, MIM, crimping, welding, soldering, or joining with adhesives

 Quantitative process development skills in areas such as (p)FMEA, tolerance analysis,

DoE, SPC, GR&R, and CpK

 Experience with Mechanical CAD (Solidworks) and PLM (Agile) software

 Prior experience with the Design Control processes for medical devices

 Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment