Senior Manufacturing Engineer - Digital Surgery

Position Title: Senior Manufacturing Engineer - Digital Surgery

Company: Acumed LLC

Req : JR

Location: Addison, TX

Time Type: Full time

Acumed LLC. As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you're doing things that matter, leading at every level, and winning a better way. We're committed to making a positive impact on the world, providing diverse learning and working opportunities, and fostering a culture where everyone's empowered to be their best.

The Senior Manufacturing Engineer (SME) is responsible for supporting the life cycle of Acumed's medical devices by meeting operational objectives in production. This position supports the manufacturing operations of patient match devices from machining and 3D printing through downstream finishing and packaging processes ensuring high-quality production aligned with regulatory standards. This includes developing, integrating, validating, and improving production processes and systems.

The Senior Manufacturing Engineer owns continuous improvement of existing processes through the elimination of waste and/or the adoption of new methods of manufacturing. The Senior Manufacturing Engineer is a co-owner of Acumed's Cost of Goods Sold (COGS) and On Time Delivery (OTD) targets. The Senior Manufacturing Engineer supports Acumed's quality-first culture by ensuring all processes are aligned to regulated Good Manufacturing Practices (GMPs).

The ideal candidate has a passion for manufacturing and can be effective in a quality-first, highly regulated environment. The Senior Manufacturing Engineer must have excellent verbal communication and technical writing skillset with demonstrated experience using analytical methods to solve problems. The Senior Manufacturing Engineer must have a customer focused, "go and see" mentality and feel comfortable in a shop floor environment.

• Lead the development, integration, validation, and continuous improvement of production processes for patient-specific medical devices.
• Own and drive improvements in Cost of Goods Sold (COGS), Operational Efficiency, and On Time Delivery (OTD).
• Ensure all manufacturing processes align with Good Manufacturing Practices (GMPs) and support Acumed's quality-first culture.
• Apply analytical methods to solve complex manufacturing challenges and eliminate waste.
• Maintain a strong presence on the shop floor to support real-time problem solving and process optimization.
• Provide technical leadership and mentorship to junior engineers, Patient Match Technicians, and cross-functional teams.
• Collaborate with case planning, quality, and operations teams.
• Identify and mitigate technical risks through strategic planning and roadmap development.
• Be trained to operate all equipment in the patient match department as a backup when the technician is out.
• Lead initiatives to adopt new manufacturing technologies and methods tailored to patient-matched production.
• Ensure compliance with FDA regulations and ISO 13485 standards throughout all engineering activities.
• Document and communicate technical findings, validations, and improvements effectively across teams.

• Bachelor's degree in Engineering (Mechanical, Manufacturing, Industrial) or equivalent.
• 5+ years of experience in manufacturing engineering or related field, preferably in medical device manufacturing.
• Previous experience in patient-specific or customized manufacturing workflows preferred.
• Experience in a regulated manufacturing industry, with knowledge of FDA and ISO 13485 standards.
• Advanced proficiency in 3D CAD software such as PTC Creo, Autodesk Inventor, Solid Works, PRO-E, or equivalent.
• Strong background in CNC machining, programming, and shop floor inspection methods.
• Background in 3D printing, SLA preferred.
• Applied understanding of Geometric Dimensioning and Tolerancing (GD&T).
• Expertise in Process Validation (IQ, OQ, PQ).
• Familiarity with specialized processing: machining, parts washing, anodization, electro-polishing, passivation, labeling and packaging (e.g., Tyvek tray sealing, vacuum sealing).
• Skilled in data-driven problem solving and root cause analysis.
• Proficient in…