Manufacturing Engineer

Job description

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