Manufacturing Engineer 3 at Acumed in Hillsboro, Oregon
Posted in General Business 30+ days ago.
Type: Full-Time
Job Description:
About Us
Acumed is a global leader of innovative orthopaedic and medical solutions developed to improve patient care. With over three decades of experience in the orthopaedic industry, our mission is to aid the afflicted through the ingenuity of our minds, the labor of our hands and the compassion of our hearts. The company is headquartered in Hillsboro, Oregon with a global sales and distribution network supported by offices worldwide.
Manufacturing Engineer 3
The Manufacturing Engineer (ME) is responsible for supporting the life cycle of Acumed 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 Acumed's Cost of Goods Sold (COGS), On Time Delivery (OTD), and New Product Introduction (NPI) targets. The Manufacturing Engineer supports Acumed's quality-first culture by ensuring Acumed 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.
Duties/Responsibilities
In addition to Level 2 duties:
- 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
- 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)
- Understanding of machining capabilities and CNC programming
- Selection and commissioning of new production equipment
- Applied experience with of Process Validation (IQ, OQ, and PQ) requirements
- Subject matter expert (SME) / key liaison of machining capabilities
- Understanding of statistical tools such as control charts, trending, and capability with experience in Minitab, JMP or equivalent
- Applied experience of shop floor inspection methods
- Applied experience of removing manufacturing constraints and improving process flow.
- Experience in a regulated manufacturing industry desired
- Knowledge of FDA and ISO 13485 Regulations
- Understanding of Risk Management and experience with tools such as FMEA
Acumed is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with a disability.
As an equal opportunity employer, Acumed is committed to providing reasonable accommodations to applicants with disabilities. If you are interested in applying to Acumed and need special assistance or accommodation, please contact us at recruiting@acumed.net .
Acumed https://acumed.applicantpro.com
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