What are the responsibilities and job description for the Sr. Operations Engineer position at Exalta Group?
EXALTA Group brings together three industry pioneers under one banner (Intech, Resolve Surgical, and Tyber Medical), reinforcing a shared objective: advancing the future of MedTech with greater clinical impact and improved patient outcomes. New website: https://exalta.com/. The Marquette, MI location is a part of the Integrated OEM Solutions business unit.
Location: On-site, Marquette, MI
POSITION SUMMARY:
Sr. Operations Engineer – Sustaining & New Product Introduction (NPI)
The Sr. Operations Engineer plays a key role in supporting both sustaining engineering activities and the successful introduction of new products within a regulated medical device manufacturing environment. This position is responsible for leading assigned engineering tasks—including compliance, process optimization, and lean initiatives—to improve product performance, support manufacturing readiness, and achieve operational metrics. The Sr. Engineer applies sound engineering judgment, selects appropriate methods and tools to solve problems, and partners effectively with senior internal and external stakeholders. This role directly supports Exalta’s mission to maximize the number of patients served while ensuring exceptional quality, safety, and reliability.
Responsibilities
- Serve as a senior-level engineer supporting both sustaining engineering efforts and NPI project execution.
- Function as a subject matter expert for assigned technologies and owner of functional tasks. Reviews and approves tasks and serves as a technical lead with customers.
- Develop, review, and maintain engineering documentation, including process instructions, test methods, change orders, risk documentation, and validation protocols.
- Drive root cause analysis, corrective/preventive actions (CAPA), and process improvements to support product quality, reliability, and manufacturability.
- Collaborate cross-functionally with R&D, design engineering, quality, supply chain, and manufacturing teams to ensure smooth product transitions from development to production.
- Support the implementation of design changes, cost-reduction initiatives, and component sourcing updates within existing product lines.
- Lead functional tasks, engineering studies, and process validations that contribute to meeting quality, productivity, and cost objectives.
- Apply lean manufacturing principles to identify waste, optimize processes, and improve operational efficiency.
- Ensure adherence to business processes and Quality Management System (QMS) requirements, contributing to overall compliance and audit readiness.
- Proactively support and mentor team members to promote shared success and knowledge transfer across the engineering organization.
*This is not an exhaustive list of duties or functions and may not necessarily comprise all of the essential functions.*
EDUCATION/EXPERIENCE REQUIRED AND/OR PREFERRED:
- Bachelor’s degree in Biomedical or Mechanical Engineering, Engineering Technology, or relevant Engineering discipline (preferably from an ABET accredited program) is required and
- 10 years’ experience in medical device or relevant industry experience preferred or a
- Master’s degree in Biomedical or Mechanical Engineering, Engineering Technology, or relevant Engineering degree and 5 years’ experience in medical device or relevant industry
- CQE, Blackbelt, and/or Six Sigma certifications preferred
KNOWLEDGE, SKILLS, AND ABILITIES:
Technical Competencies
- A subject matter expert (SME) in one or more engineering disciplines
- Fundamental knowledge and experience in spine and orthopedic medical device technologies
- Ability to adapt, lead, and support continuous improvements
- Mastery of Resolve’s Quality Management Systems (QMS)
- Strong statistical skills
- GD&T and print reading
- CAD/Drafting
Behavioral & Basic Skill Competencies
- Customer-first attitude
- Strong organization and time-management skills
- Ability to build and maintain effective cross-functional relationships.
- Strong interpersonal communication and presentation skills (verbal, written, and visual)
- Strong mentor and leadership skills
- Ability to lead technical problem solving and other company initiatives