Applications Engineer

Applications Engineer

Applications Engineering is a vital link between the customer, engineering, and production teams. This role ensures technical support, customer satisfaction, and project execution for medical device manufacturing projects. The engineer will act as a technical expert, supporting customers throughout the product lifecycle from concept to production.The purpose of this role is to provide Engineering support to daily production activities for medical device manufacturing. The position requires an expertise in medical device manufacturing applications including Swiss machining, Flute Grinding, CNC Programming, work holding, tooling and fixture designs.

Essential Functions:

Applications Engineering

1. Collaborate with customers to understand their technical requirements and translate them into manufacturing solutions.
2. Assist in developing design-for-manufacturing (DFM) solutions to ensure product quality and cost-efficiency.
3. Generate technical documentation such as process routings, manufacturing prints, and inspection documents.
4. Recommend material selection, tooling designs, and manufacturing processes based on project needs.
5. Proficiency in CAD software (e.g., SolidWorks), GD&T, and technical drawing interpretation.
6. Proficiency designing tooling, fixturing and manufacturing systems utilizing 3D Modeling software.
7. Strong Blueprint reading skills
8. Maintains technical knowledge by attending seminars and selected training programs to advance skillset.
9. Familiarity with ISO 13485, FDA regulations, and GMP principles.

Customer Support & Relationship Management

10. Serve as the primary technical point of contact for customer inquiries, ensuring timely and accurate responses.
11. Develop and maintain strong customer relationships through regular communication and proactive support.
12. Assist customers with technical challenges, troubleshooting, and problem resolution.
13. Provide product and process guidance to customers during design, development, and manufacturing stages.
14. Excellent verbal and written communication skills to interact with customers and internal teams, with strong interpersonal skills

Project Management

15. Manage customer projects from initial inquiry to final delivery, ensuring deadlines and quality standards are met.
16. Coordinate internal teams across engineering, quality, and production to address customer requirements.
17. Track progress and provide updates to stakeholders regarding project status, risks, and required actions.
18. Product/Process Validation and maintenance.
19. Demonstrated ability to run multiple projects and exhibit strong accountability to achieve scheduled milestones and deliverables.
20. Knowledge in Lean Manufacturing Processes.
21. Experience with Microsoft Project, Microsoft Office, E2 and other relevant software systems.
22. Positive attitude, team player.

Documentation & Compliance

23. Prepare and maintain documentation for customer-specific requirements, quality standards, and process controls.
24. Ensure compliance with regulatory standards such as ISO 13485, FDA requirements, and GMP guidelines.
25. Collaborate with quality engineers to support documentation for inspections, audits, and validation processes.

Experience Requirements:

BS degree in Engineering with at least seven (7) years demonstrated successful performance/experience in an applicable Engineering position. Must have experience in hands on engineering positions involving Machining, Grinding and CNC programming. Ideal candidate would have background in Medical Device manufacturing. Project Management experience a plus.

Education Requirements:

1.Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related technical field.

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance