Senior Manufacturing Engineer

Job Title: Senior Manufacturing Engineer Job Type: Full-time direct hire Job Location: Hillsboro, OR (Onsite) Salary: DoE Work Authorisation: US Citizen/GC Job Description The Manufacturing Engineer (ME) is responsible for supporting the life cycle of medical devices by meeting operational objectives in production and new product development. This includes developing, integrating, validating and improving production processes and systems. The ME owns continuous improvement of existing processes through the elimination of waste and / or the adoption of new methods of manufacturing. The Manufacturing Engineer is a co-owner of our Cost of Goods Sold (COGS), On Time Delivery (OTD), and New Product Introduction (NPI) targets. The Manufacturing Engineer supports our quality-first culture by ensuring our processes are aligned to regulated Good Manufacturing Practices (GMPs). The ideal candidate has a passion for manufacturing and can be effective in a quality-first, highly regulated environment. The Manufacturing Engineer must have excellent verbal communication and technical writing skillset with demonstrated experience using analytical methods to solve problems. The Manufacturing Engineer must have a “go and see” mentality and feel comfortable in a shop floor environment. Responsibilities Provides manufacturing engineering expertise with specific emphasis on achieving: DFM/A-Design for Manufacturability / Assembly and high product Quality – through detailed process characterization, process documentations, equipment, tools, fixtures, jigs, and qualification. Manages all manufacturing details of new product launches Develops and implements advanced inspection methods and gaging Manages corrective/preventative actions (CAR/SCAR) Evaluates inspection frequency considering risk management and process capability Uses appropriate statistical techniques to develop validation protocols, complete process capability studies and process validation on processes. Actively participate in other team activities to help insure total team success. Leads system level Process Improvement (Pi) initiatives and implements Lean tools Reviews and approves Process Validation protocols and reports Prepares new equipment proposals including ROI justification Manages technical operational projects Leads cross-functional groups Communicates effectively with all levels of the organization Qualifications B.S. Degree in Engineering (Mechanical, Manufacturing, Industrial) or equivalent 5+ years manufacturing engineering or related experience Advanced 3D CAD experience in Autodesk Inventor, Solidworks, PRO-E or equivalent Applied understanding of Geometric Dimensioning and Tolerancing (GD&T) Add understanding of machining capabilities, CNC programming Selection and commissioning of new production equipment Applied experience with of Process Validation (IQ, OQ, and PQ) requirements Applied experience with statistical tools such as control charts, trending, and capability with Minitab, JMP or equivalent. Job Type: Full-time Pay: $69,829.98 - $120,000.00 per year Benefits: Health insurance Experience level: 5 years Schedule: 8 hour shift Work setting: In-person Manufacturing facility Ability to commute/relocate: Hillsboro, OR 97124: Reliably commute or planning to relocate before starting work (Required) Experience: Cost of Goods Sold: 2 years (Required) Good Manufacturing Practices (GMP): 5 years (Required) CNC programming: 5 years (Required) 3D CAD: 5 years (Required) Autodesk: 4 years (Required) Work Location: In person