Sr. Manufacturing Engineer - Additive

Rms Surgical, Inc.; Coon Rapids (MN); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Onsite Clinic

Parental Leave

Tuition Reimbursement

Wellness Program

Job summary

rms Company seeks aSenior Additive Manufacturing Engineer to lead metal AM development for surgical implants. You will drive industrialization, process validation, and scalable production across DFAM and lattice structures.

Collaborate across quality, regulatory, and operations to translate R&D into manufacturable medical products while ensuring FDA and ISO 13485 compliance.

Qualifications

• Bachelor's degree in mechanical/biomedical related field; advanced degree preferred.
• 7+ years in additive manufacturing and medical device environments.
• Experience with metal AM, implants, and regulated production workflows.

Responsibilities

• Lead development and optimization of metal AM processes for medical devices.
• Design and validate DFAM strategies for complex implant geometries.
• Ensure process validation, equipment selection, and scale-up activities.
• Collaborate with quality/regulatory to maintain FDA/ISO 13485 compliance.
• Translate R&D concepts into manufacturable, scalable production solutions.

Skills

Metal AM

Process development

DFAM

L-PBF & EB-PBF

Education

Bachelor's in Mechanical Engineering

Advanced degree preferred

Tools

SolidWorks

3DXpert

Materialise MAGICS

Job description

Overview

About rms Company

rms is a state of the art facility with the latest technology in precision machines to produce components for the medical device and aerospace industries. Our Manufacturing Engineers provideengineering support to rms teams with particular emphasis on developing capable manufacturing processes, implementing cellular manufacturing techniques and certifying processes to provide superior products to our customers.

Position Summary

We are seeking a highly motivated and technically accomplished Senior Additive Manufacturing Engineer to lead the development, industrialization, and optimization of advanced metal additive manufacturing technologies for medical device applications. This role combines responsibilities across R&D, process development, project engineering, and manufacturing engineering to support the full product lifecycle from concept through commercialization.

The ideal candidate will possess deep expertise in metal additive manufacturing, orthopedic implant development, materials engineering, and scalable production systems. This individual will interface cross-functionally with customers, operations, quality, regulatory, facilities, manufacturing, and executive leadership to translate innovative concepts into validated, manufacturable medical products.

This position requires strong technical leadership, project management capability, and hands‑on engineering experience within regulated medical device manufacturing environments.

Responsibilities

Essential Job Functions

• Lead development and implementation of advanced metal additive manufacturing processes for orthopedic and medical device applications.
• Design, validate, and optimize production-ready AM workflows including build strategy, support design, post-processing, inspection, and quality controls.
• Develop Design for Additive Manufacturing (DFAM) strategies for complex implant geometries and lattice structures.
• Establish and improve additive manufacturing capabilities including equipment selection, lab setup, process validation, and manufacturing scale-up.
• Support material characterization activities including mechanical testing, microstructural analysis, chemistry analysis, and process capability studies.
• Drive continuous improvement initiatives focused on throughput, quality, scrap reduction, cycle time, and manufacturability.
• Lead cross-functional engineering projects from concept through commercialization.
• Develop and execute engineering studies, validation protocols, and testing plans in compliance with FDA, ISO 13485 and internal quality requirements.
• Translate R&D concepts into manufacturable and scalable production solutions.
• Participate in customer-facing technical discussions, DFM reviews, and project milestone meetings.
• Understand and comply with the Cretex professional competencies, company policies, and the employee manual
• Collaborate with Quality Engineering to develop validated and capable manufacturing processes.
• Support root cause investigations, CAPA activities, and non-conformance resolution.
• Ensure appropriate documentation practices for protocols, work instructions, validation reports, and engineering records.
• Adhere to all safety policies; including wearing personal protective equipment when required
• Support and comply with the company's QMS (Quality Management System), ISO 9001 and 13485 standards, GMP's (Good Manufacturing Practices), and GDP's (Good Documentation Practi

Qualifications

Minimum Requirements, Education & Experience (incl. KSA’s and certifications)

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, Metallurgical Engineering, Manufacturing Engineering, or related field. Advanced degree preferred.
• 7+ years of engineering experience in additive manufacturing and medical device manufacturing environments.
• Strong, hands‑on experience with metal additive manufacturing technologies including L-PBF and EB-PBF powder bed fusion systems.
• Experience developing manufacturing processes for orthopedic implants or regulated medical devices.
• Strong understanding of AM materials, microstructures, and production workflows.
• Experience with process validation, manufacturing scale-up, and production support.
• Knowledge of ASTM standards related to additive manufacturing and implant materials including ASTM F3001 preferred.
• Proficiency with CAD software such as SolidWorks, Creo, NX, or equivalent.
• Proficiency with Additive Manufacturing software such as 3DXpert or Materialise MAGICS.

Desirable Criteria & Qualifications

• Experience building or expanding additive manufacturing capabilities from the ground up.
• Knowledge of machining processes (AM Machines, CNC, inspection methods, and properties of materials)
• Experience with root cause analysis, Lean Manufacturing, and continuous improvement methodologies.
• Experience developing FDA-cleared lattice or porous implant structures.
• Experience with ISO 17025 laboratory systems and materials testing methodologies.
• Familiarity with automation, digital manufacturing, and advanced inspection systems.
• Experience interfacing with surgeons, regulatory agencies, and external customers.
• Experience transitioning R&D technologies into full-scale production environments.
• Experience with Colibrium Spectra M Equipment.
• Proven ability to translate R&D innovation into scalable, manufacturable medical products.

rms Company Benefits

As a Cretex Medical company, rms offers a full benefit package to its employees. Benefits include medical, dental, vision and life insurance options. rms also offers a 401(k) retirement plan with employer match, profit sharing, short- and long-term disability insurance, paid time off, holiday pay, and an onsite medical clinic.

rms Company also offers company specific benefits, such as:

• Onsite Clinic
• Paid Parental Leave
• Monthly Social Events
• Annual Employee Appreciation Week
• Volunteer Opportunities
• Training and Development Opportunities
• Tuition Reimbursement
• Wellness Program

Cretex Companies use cutting oils, solvents, and other chemicals in the manufacturing process. Testing is conducted on a periodic basis to ensure all chemicals are kept well below the OSHA permissible exposure levels.

#LI-MH1

Pay Range

USD $100,000.00 - USD $140,000.00 /Yr.

Company Benefits

All Employees:

Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees.

20+hours:

Cretex’s medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre‑tax health savings account, healthcare and dependent care pre‑tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week.

30+ hours:

Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week.

(Some benefits are subject to eligibility criteria.)

Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law.

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.