Mechanical / MFG Engineer

Dilon Technologies; Newport News (VA); Hybrid; USD 80,000 - 110,000; Full time

Job summary

Dilon Technologies in Newport News, Virginia, is seeking a Mechanical / Manufacturing Engineer to design the mechanical side of next-generation medical devices and ensure reliable scale-up. This hybrid role splits time between new product development and manufacturing engineering in support of production.

You will collaborate across systems, electrical, software, and test teams, guide design transfer to production, and drive continuous improvement on yield and cost while adhering to 21 CFR 820

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 5+ years of mechanical design experience, preferably in medical devices.
• Hands-on manufacturing engineering experience with assembly processes, fixtures, and production support.
• Proficiency in SolidWorks, GD&T, and tolerance analysis.
• Familiarity with design controls and quality systems (21 CFR 820, ISO 13485).
• Experience with IQ/OQ/PQ process validation and root cause analysis tools.
• Knowledge of machining, injection molding, sheet metal, and electromechanical assembly.

Responsibilities

• Lead mechanical design from concept to production release for next-generation medical devices.
• Develop and maintain assembly processes, fixtures, and work instructions for production builds.
• Lead design transfer, pilot builds, and production test strategy.
• Support the production floor with issue resolution and CAPA.
• Collaborate with systems, electrical, software, and test engineers to ensure robust designs.

Skills

Mechanical design

Manufacturing engineering

CAD

GD&T

Tolerance analysis

Design for manufacturing

Documentation writing

Regulatory knowledge (21 CFR 820 / ISO

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Arena PLM

Job description

Mechanical / Manufacturing Engineer

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

About Dilon Technologies

Dilon Technologies is an innovative medical device company headquartered in Newport News, Virginia, dedicated to advancing breast health through cutting-edge medical technologies. With a focus on improving patient outcomes, Dilon develops and commercializes solutions that support healthcare professionals in the detection, diagnosis, and treatment of breast cancer.

Our product portfolio includes MarginProbe, Navigator, and TrueView, technologies designed to enhance surgical precision, improve clinical decision-making, and support quality patient care.

At Dilon, we are committed to innovation, collaboration, and continuous improvement. Our team offers employees the opportunity to work in a dynamic, hands-on environment where individual contributions make a meaningful difference.

Our mission is to provide innovative medical technologies that empower healthcare professionals and improve the lives of patients.

About the Role

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.

What You’ll Do: Mechanical Design (~50%)

• 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.

What You’ll Do: Manufacturing Engineering (~50%)

• 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.

What We’re Looking For

• 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.

Nice to Have

• 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.

Why Join Us

• 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.