Mechanical / Manufacturing Engineer

About Dilon Technologies

Dilon Technologies is an innovative medical device company headquartered in Newport News, Virginia, dedicated to advancing breast health and improving patient outcomes. Our portfolio of cutting-edge technologies, including MarginProbe®, Navigator®, and TrueView®, helps physicians make more informed decisions and deliver exceptional patient care.

At Dilon, we're passionate about making a difference. Our team thrives on innovation, collaboration, and a shared commitment to bringing meaningful medical technologies to market. We offer a dynamic, hands-on environment where employees can take ownership, contribute ideas, grow professionally, and see the direct impact of their work.

If you're motivated, enjoy a challenge, and want to be part of a team where your contributions truly matter, we'd love to hear from you!

Mechanical / Manufacturing Engineer

Dilon Technologies | Engineering | Full-time | On-site 

Dilon Technologies is looking for a Mechanical / Manufacturing Engineer to design the mechanical side of our next-generation medical devices and make sure they can be built reliably at scale. This is a hybrid role: about half new product development (mechanical design) and half manufacturing engineering in support of production.

You’ll be the team’s mechanical expert, working closely with our systems, electrical, software, and test engineers on new products, and with operations on the production floor. We’re focused on new product development, so the design side of this role is a priority, not an afterthought.

• Product design: Design enclosures, housings, mechanisms, shielding, and structural components for medical devices, from concept through production release.

• CAD and drawings: Create 3D models, assemblies, and fully toleranced 2D drawings using GD&T in SolidWorks.

• Analysis: Perform tolerance stack-ups, material selection, and engineering analysis (structural, thermal, drop/impact) as needed.

• DFM/DFA: Design for manufacturability, assembly, cleaning/disinfection, and serviceability, applying your manufacturing experience early in the design.

• Prototyping: Build and test prototypes; work with machine shops, molders, and other suppliers on rapid iterations.

• Design controls: Work with the systems engineer on mechanical requirements, interfaces, and risk analysis; support V&V testing of mechanical features.

• Documentation: Write design documentation for the DHF, including design rationale, test[KL1] [SB2] plans, protocols, reports, and inputs to design reviews.

• Biocompatibility: Select materials with biocompatibility in mind, and support biological evaluation per ISO 10993-1, including biological evaluation plans, test plans, and coordination with external test labs. Also support cleaning/disinfection compatibility as needed.

• Processes and work instructions: Develop and maintain assembly processes, work instructions, and travelers for production builds.

• Fixtures and tooling: Design and qualify fixtures, tooling, and assembly aids.

• Process validation: Lead process validation (IQ/OQ/PQ) and test method validation for manufacturing processes.

• Production support: Support the production floor: troubleshoot build issues, disposition nonconforming material (NCMRs), and drive root cause and corrective action (CAPA).

• Suppliers: Qualify suppliers and components, work through supplier quality issues, and handle part obsolescence and second-sourcing.

• Change control: Own engineering change orders (ECOs) for mechanical parts and manufacturing documentation in our PLM system (Arena).

• Design transfer: Lead design transfer of new products into production, including pilot builds, process readiness, and production test strategy.

• Continuous improvement: Identify and implement yield, cost, and cycle-time improvements.

• Bachelor’s degree in Mechanical Engineering or a related field.

• [5+] years of mechanical design experience, preferably in medical devices or another regulated industry.

• Hands-on manufacturing engineering experience, including assembly processes, fixtures, and production support.

• Demonstrated Expertise in SolidWorks, GD&T, and tolerance analysis.

• Working knowledge of design controls and quality systems under 21 CFR 820 / ISO 13485.

• Experience with process validation (IQ/OQ/PQ) and root cause analysis tools.

• Familiarity with common manufacturing processes such as machining, injection molding, sheet metal, and electromechanical assembly.

• Clear technical writing. You can produce work instructions, protocols, and reports that others can follow.

• The ability to balance design priorities with day-to-day production needs, and to flag when one is crowding out the other.

• Collaborative and professional. You build good working relationships with engineers, production staff, and suppliers.

• Experience with radiation shielding (e.g., tungsten, lead) or detector/imaging device mechanics.

• Experience with IEC 60601-1 mechanical requirements (enclosures, mechanical hazards, ingress protection).

• Experience with sealed or waterproof designs, cleaning/disinfection compatibility, and biocompatibility considerations.

• Experience with FEA tools and statistical methods (DOE, Cpk).

• Experience with Arena PLM or a similar PLM/eQMS system.

• Design what we build next. You’ll own the mechanical design of new products from concept to production.

• See your work through end to end, from CAD to the production floor.

• A small, collaborative team where your expertise is visible and valued.

Dilon Technologies is an equal opportunity employer. We do not discriminate based on race, color, religion, sex, national origin, age, disability, or any other protected characteristic under applicable law.