Sr. Manufacturing Engineer - Additive

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

Benefits offered by this job

Medical, dental, vision, and life insurance options

401(k) retirement plan with employer match

Paid time off and holiday pay

Training and development opportunities

Tuition reimbursement

Wellness program

Job summary

Cretex Companies, Inc. is looking for a Senior Additive Manufacturing Engineer to spearhead the development and optimization of advanced metal additive manufacturing technologies for medical devices. This role blends R&D and project engineering to enhance production capabilities. Candidates should have over 7 years of experience and a strong understanding of additive manufacturing processes.

The ideal candidate will possess expertise in orthopedic implants, project management skills, and the ability to collaborate cross-functionally to bring innovative concepts to life.

Qualifications

• 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.
• Advanced degree preferred.

Responsibilities

• Lead the development and implementation of advanced metal additive manufacturing processes.
• Design, validate, and optimize production-ready AM workflows.
• Support material characterization activities and development of Design for Additive Manufacturing (DFAM) strategies.

Skills

Metal additive manufacturing

Orthopedic implant development

Project management

Process validation

Education

Bachelor’s degree in Mechanical Engineering or related field

Tools

SolidWorks

3DXpert

Job description

Overview

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 provide engineering 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

• 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 Practices).

Qualifications

• 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.

Benefits

• Medical, dental, vision, and life insurance options.
• 401(k) retirement plan with employer match and profit sharing.
• Short‑ and long‑term disability insurance.
• Paid time off, holiday pay, and an onsite medical clinic.
• Onsite clinic.
• Paid parental leave.
• Monthly social events.
• Annual employee appreciation week.
• Volunteer opportunities.
• Training and development opportunities.
• Tuition reimbursement.
• Wellness program.

Pay Range

USD $100,000.00 - USD $140,000.00 per year.

Equal Employment Opportunity Statement

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.