Job Description
Engineer II - Additive Manufacturing Position Profile This is a
100% onsite opportunity . The selected candidate will be required to work from one of the following locations:
- Parma, OH
- Indianapolis, IN
The Additive Manufacturing Engineer plays a key role in the Ricoh 3D for Healthcare team's goal of onboarding customers through the intake of projects including both partner production and patient-specific models. Responsibilities include interpretation of 3D models and CAD drawings, process translation and development, equipment validation, and material resourcing and characterization. The Additive Manufacturing Engineer translates the technical needs of the customer to the production team and develops new or enhances existing infrastructure to additively manufacture new products.
Job Duties and Responsibilities Work with customers, engineering, and production teams to intake production orders, review for manufacturability, and process into production.
Support intake and implementation of production work: review/develop customer requirements, lead prototyping efforts, process development, write process documents, and transfer to production.
Lead projects to improve quality, process stability, and reduce cost while meeting customer requirements.
Develop knowledge in in-situ (live) monitoring of AM machine builds.
Analyze AM build failures and implement countermeasures.
Lead and perform new and existing product/process validations and support First Article Inspection.
Set up AM build jobs, run AM machines, and document the process clearly.
Write SOPs and work instructions for incoming contract manufacturing.
Ensure compliance with ASTM, ISO 13485, FDA, and other standards for medical device manufacturing.
Act as Subject Matter Expert for assigned processes; support audits (customer, ISO, FDA, internal).
Collaborate on the design/fabrication of jigs, tools, fixtures, gauges, and special equipment.
Drive continuous improvement activities focusing on quality, efficiency, and cost reduction.
Participate in new product pre-production meetings to ensure readiness of manufacturing processes.
Review and monitor quality and process improvements across manufacturing, supply chain, and QA.
Develop, implement, and manage PFMEAs and risk mitigation strategies.
Manage project responsibilities: development, documentation, operator training.
Collaborate with Quality Engineering to develop quality plans ensuring GMP compliance.
Operate 3D printers and post-processing equipment (alkaline baths, pressure blasters, UV chambers, etc.).
Participate in Material Review Board (MRB) for internal non-conformances and customer returns.
Develop inspection/validation steps and integrate into manufacturing instructions.
Support internal/external design projects and transition prototypes into production.
Write protocols, analyze test data, and generate validation reports (FEA, tolerance analysis, etc.).
Investigate production/product quality issues, identify root causes, and implement corrective actions.
Coordinate with Sales on pricing, orders, and invoicing issues.
Build and maintain effective communication with co-workers, vendors, and customers.
Assist with data requests from regulatory departments (e.g., FDA 510K submissions).
Perform other duties as assigned.
Qualifications (Education, Experience, Certifications) BS in Engineering; experience in medical 3D printing/additive manufacturing strongly preferred (equivalent experience considered).
Degree or certification in 3D printing or related field preferred.
2-4 years of experience in FDA-regulated or QMS environment producing medical devices required.
Proficiency in 3D CAD software and AM-related tools required.
Experience in contract manufacturing project management preferred.
Familiarity with standards: ASTM, ISO 9000, ISO 13485, ISO 14971, 21 CFR.
Proficiency with standard business software.
Prior experience in customer service strongly preferred.
Knowledge, Skills, and Abilities Strong sense of ownership; self-motivated and hands-on.
Goal-oriented with ability to set and achieve ambitious targets.
Excellent communication and teamwork skills; able to present to peers, customers, and regulators.
Solid understanding of material selection, modeling, simulation, and design optimization.
In-depth knowledge of additive manufacturing and design for AM.
Ability to interpret and produce technical documentation.
Strong customer service mindset with follow-through.
Analytical skills to identify issues and implement practical solutions.
Experience with post-processing tools and techniques (e.g., vapor smoothing, GD&T, ultrasonic cleaning).
Effective project execution and workflow improvement skills.
Ability to handle varied tasks and adapt to change in a dynamic environment.
Strong organizational, problem-solving, and time management skills.
High-performance mindset with clear execution standards.
Must be able to multi-task, self-motivated, enthusiastic, and possess strong work ethic.
Working Conditions / Mental and Physical Demands Work in office and manufacturing environments.
Careful handling of delicate parts required.
Regular communication with engineering manager and customers.
May require long periods of standing or walking.
Moderate dexterity for standard tools and equipment.
Occasional business travel required.
Job Tags
Contract work, Work at office,