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Acumed · 1 day ago

Senior Manufacturing Engineer - Digital Surgery

Addison, TX

Full-time

Onsite

Senior Level

5+ years exp

Acumed LLC is part of the global industrial organization Marmon Holdings, focused on making a positive impact in the world. The Senior Manufacturing Engineer is responsible for supporting the life cycle of medical devices, ensuring high-quality production aligned with regulatory standards, and driving continuous improvement in manufacturing processes.

Health CareManufacturingMedical Device

Responsibilities

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

Qualification

Manufacturing EngineeringFDA RegulationsISO 13485 Standards3D CAD SoftwareCNC MachiningProcess ValidationData-driven Problem SolvingGeometric DimensioningTolerancingTechnical WritingTeam CollaborationInterpersonal SkillsLeadership

Required

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

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, SolidWorks, PRO-E, or equivalent

Strong background in CNC machining, programming, and shop floor inspection methods

Applied understanding of Geometric Dimensioning and Tolerancing (GD&T)

Expertise in Process Validation (IQ, OQ, PQ)

Skilled in data-driven problem solving and root cause analysis

Proficient in statistical tools such as control charts, trending, and capability analysis using Minitab, JMP, or equivalent

Understanding of Risk Management and experience with tools such as FMEA

Excellent verbal and written communication skills

Demonstrated leadership in cross-functional teams and mentorship

Ability to work effectively in a highly regulated, quality-first environment

Strong team collaboration and interpersonal skills

Preferred

Previous experience in patient-specific or customized manufacturing workflows preferred

Background in 3D printing, SLA preferred

Familiarity with specialized processing: machining, parts washing, anodization, electro-polishing, passivation, labeling and packaging (e.g., Tyvek tray sealing, vacuum sealing)