Process Development Engineer II - Seattle at 3D Systems in Rock Hill, South Carolina

Job Description:

Who We Are:

More than 30 years ago, 3D Systems brought the innovation of 3D printing to the manufacturing industry. Today, as the leading additive manufacturing solutions partner, we bring innovation, performance, and reliability to every interaction - empowering our customers to create products and business models never before possible. 3D Systems' solutions address a variety of advanced applications in healthcare and industrial markets such as medical and dental, aerospace & defense, automotive, and durable goods.

3D Mission Statement: With advanced hardware, software and materials as well as on demand manufacturing services and a global team of experts, we are on a mission to transform businesses through manufacturing innovation.

Who We Support & Work With:

3D Systems Healthcare is supporting the onboarding of additive manufacturing capabilities and a quality management system within the Veteran's Health Administration (VHA) at multiple medical centers across the country. The VHA Innovation Ecosystem (IE) mission is to enable the discovery and spread of healthcare innovations within VHA that exceed expectations, restore hope, and builds trust within the Veteran community. Working with VHA doctors, nurses, Veterans, educators, and private industry across the country.

Where You Will Work:

This position will be located onsite at the VA Hospital site in Seattle, Washington. The VHA site in Seattle, Washington is expanding rapidly and needs a skilled Process/Manufacturing Engineer to add to the existing Operations team. The mission of the Operations team is to develop and sustain manufacturing processes for patient-specific medical devices, both in-house and out-sourced, to improve cost, quality, and capacity. This position will primarily support the production activities related to ongoing product development and future product lines leveraging additive manufacturing technologies and other traditional manufacturing methods.

What You Will Do:

These factors will determine success for this position:

With broad guidance, and previous experience, selects method and makes necessary assumptions to determine proper model orientation and support structure required to achieve technical characteristics and successfully print a 3D component on a variety of machines and materials. Provides design coordination for engineers and technical staff through the use of Computer Aided Design (CAD) models. Establishes production plans, in-process quality control and cost estimates in support of the 3D print.

Within overall assignments, incumbent leads the development of process validation and verification efforts by creating a thorough understanding of machine and process variables. Machine and process variables will be examined through Design of Experiments (DoE) prior to validation. Additionally the incumbent will lead creation of process failure mode and effects analysis (pFMEA) documents. Develops test protocols and assists operators with execution of test protocols. Upon completion of testing, analyzes data and creates test reports.

Establishes processes for development, production, and sustainment. Phases include: process development; medical scan reconstruction; design influence for manufacturing; additive manufacturing ; rapid prototyping; manufacturing technology; design of tools and fixtures to aid with process efficiency. Assists with the development of procedures and methods for the manufacture of medical models, devices, and research and development (R&D) initiatives. Identifies proper materials based on requirements, dimensional tolerances, and secondary processing such as finishing.

Establishes quality assurance processes, process documentation/standard operating procedures; process control; quality control, quality acceptance test planning and conduct; destructive and non-destructive testing; and inspection in compliance with existing quality management system SOPs. Designs, sets up and conducts testing of items or systems during the R&D, production, and sustainment phases, as needed.

Serves as technical subject matter expert on fabrication equipment and performs maintenance and troubleshooting activities to maintain equipment's function per manufacturer's specifications. Completes training requirements as necessary to have a full understanding of the equipment's operational abilities and will occasionally operate equipment with the technical team members.

Serves as a technical consultant to staff engineers and supervisor for efficient and effective production/quality/manufacturing for programs of record and urgent need projects, with the majority of projects involving medically related models, products, or systems. Evaluates tasks independently with respect to product requirements and related data to make recommendations on alternative approaches and execution. Modifies existing products or prototypes, design of applicable quality test processes, or complete fabrication of systems to meet customer requirements.

Develops an in-depth understanding of medical device regulatory guidance, internal quality management system SOPs, and VHA medical center regulations through internal training, continued education, consulting with internal and external SMEs for medical device regulation and reading existing literature on regulatory requirements.

What We Will Need From You:

• Bachelor's Degree in Engineering is required
• Minimum of 2 years of experience supporting controlled/regulated manufacturing operations, preferably in the medical device industry under FDA/ISO 13485 design controls or it is also desired if prior experience in the aerospace industry under AS9100. Candidates should be comfortable working in and creating content for the methodical, structured, and well-documented manner expected in a highly-regulated industry.
• Solid understanding and background in core manufacturing engineering fundamentals, such as process development, light design work, data analysis, statistics, testing/inspection, supplier interaction, structured problem solving tools, change control, and process validation.
• Broad practical knowledge and skill in using, computer-aided design (CAD), modeling software including mesh modeling and slicing software, 3D scanning and manipulating scans in CAD software.
• Broad practical knowledge and skill in using 3D printers of multiple fabrication processes, including not but limited to FDM, SLA, cDLM, PolyJet/Multi-Fusion and SLS. Must be capable of selecting the appropriate fabrication process for the task assigned.
• Thorough understanding of material properties and which material applies to the fabrication process being utilized. Incumbent must be able to select the appropriate material to use for the application of the device being produced.
• Understanding of different failure modes and how they are applicable to different processes, different applications and different geometries thus knowing the weaknesses amongst the fabrication process of choice.
• Experience working in a cross-functional and collaborative environment will be essential to your ability to function effectively at 3D Systems/VHA.
• The successful candidate will have a track record of technical accomplishments in engineering that show they are a self-starter capable of making good technical judgments and able to work independently leading technical problem solving efforts.

What you will want to know:

• In addition to a salary, this position is eligible for an annual bonus based upon company performance!
• 3D Systems offers a comprehensive benefit package including medical, dental and vision coverage, company-paid short-term and long-term disability insurance, and company-paid basic life insurance. Sick Leave, Flex (Vacation) Time, Parental Leave, and paid time off for recognized holidays. 3D Systems also provides a 401(k) Retirement Savings Plan option with a company match.

Come be a part of an organization that conducts business with integrity, values diversity in people and ideas, and is a positive force for action within and for the communities we serve. We're very much looking forward to hearing from you so that we may learn more about you! Thank you for making 3D Systems your potential choice of career path!

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