Senior Manufacturing Engineer Digital Surgery

Addison, TX - USA

Monthly Salary: Not Disclosed

Posted on: 2 hours ago

Vacancies: 1 Vacancy

Job Summary

Acumed LLC

As a part of the global industrial organization Marmon Holdingswhich is backed by Berkshire Hathawayyoull be doing things that matter leading at every level and winning a better way. Were committed to making a positive impact on the world providing you with diverse learning and working opportunities and fostering a culture where everyones empowered to be their best.

Job Scope

The Senior Manufacturing Engineer (SME) is responsible for supporting the life cycle of Acumeds 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 Acumeds Cost of Goods Sold (COGS) and On Time Delivery (OTD) targets. The Senior Manufacturing Engineer supports Acumeds 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.

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 Acumeds 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.

Qualifications

Bachelors 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 SolidWorks 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 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.

Following receipt of a conditional offer of employment candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process please email your request to and please be sure to include the title and the location of the position for which you are applying.

Required Experience:

Senior IC

Acumed LLCAs a part of the global industrial organization Marmon Holdingswhich is backed by Berkshire Hathawayyoull be doing things that matter leading at every level and winning a better way. Were committed to making a positive impact on the world providing you with diverse learning and working opp...