Engineer II - Sustaining & NPI

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 part of the Integrated OEM Solutions business unit.

Location: Onsite, Marquette, MI

Position Summary

Engineer II – Sustaining & New Product Introduction (NPI)

The Engineer II 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 Engineer II 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 an intermediate-level engineer supporting both sustaining engineering efforts and NPI project execution.
• Function as a subject matter expert for one or more assigned technologies, while continuously seeking opportunities to expand technical knowledge and capabilities.
• 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
• 5 years’ experience in med tech or relevant industry (aerospace, automotive, or pharmaceutical) experience preferred or Master’s degree plus 1 or more years of experience preferred in lieu of
  
  

Knowledge, Skills, And Abilities

Technical Competencies

• Fundamental knowledge in spine and orthopedic medical device technologies
• Ability to adapt and support continuous improvements
• Ability to navigate the company’s Quality Management Systems (QMS)
• Strong understanding of a manufacturing environment
• Strong statistical skills
• GD&T and print reading
• CAD/Drafting
  
  

Behavioral & Basic Skill Competencies

• Customer-first attitude
• Trains, practices, and pursues learning
• Critical thinking and problem solving
• Strong ability to problem-solve and determine root cause analysis for engineering issues
• Comfortable with communicating and presenting technical issues
• Ability to build effective cross-functional relationships
• Great oral, written, and presentation skills