Manufacturing Engineer

Sunrise Systems, Inc.; Austin (TX); On-site; USD 61,992 - 64,747; Full time

Job summary

A leading healthcare technology firm in Austin, TX is seeking a Senior Manufacturing Engineer to lead complex manufacturing transfer projects. This role requires a Bachelor's degree and 4+ years of relevant experience, with skills in process validation and project management. Candidates should be collaborative and capable of managing multiple priorities in a fast-paced environment. Experience in medical device manufacturing is preferred. Competitive hourly pay of $45.00 to $47.00.

Qualifications

• Minimum of 4 years of experience in medical device manufacturing or regulated industries.
• Proven track record in manufacturing transfers or new product launches.
• Strong knowledge of process validation and manufacturing documentation.

Responsibilities

• Execute end-to-end manufacturing and site transfer projects.
• Coordinate all technical documentation and readiness activities.
• Prepare and maintain project documentation, including validation protocols.

Skills

Problem-solving

Communication

Organizational skills

Education

Bachelor's degree in engineering, science, or related discipline

Tools

ERP systems

PLM systems

MES systems

Job description

Pay Range

Base pay range: $45.00/hr - $47.00/hr

Senior Recruiter pay details provided by Sunrise Systems, Inc.

Senior Recruiter – Manufacturing Engineer, Sr.

Job Title: Manufacturing Engineer, Sr

Location: Austin, TX

Duration: 6 Months

Position Type: W2 Contract

Description

At Client, we design and manufacture technology that takes the limits off living. Are you ready to apply your engineering expertise to work that truly makes a difference? Join our U.S. Orthopedics team as a Contract Senior Manufacturing Transfer Engineer and play a key role in ensuring our orthopedic products are manufactured and delivered with excellence. This is an exciting short‑term opportunity for an experienced engineer to lead complex site and manufacturing transfer projects that directly impact patient outcomes.

What You’ll Do

As a member of the U.S. Orthopedics Operations Engineering team, you’ll lead the planning and execution of manufacturing transfers across our global network. You’ll coordinate technical readiness, validation activities, and process documentation to ensure smooth transitions between manufacturing sites—while maintaining client’s world‑class standards for quality, safety, and compliance.

Key Responsibilities

• Execute end‑to‑end manufacturing and site transfer projects, including planning, risk assessment, validation, and handover.
• Coordinate all technical documentation, process flows, and equipment readiness activities at both sending and receiving sites.
• Support process and equipment validation (IQ/OQ/PQ) and ensure compliance with FDA and ISO 13485 requirements.
• Partner cross‑functionally with Quality, Regulatory, Supply Chain, Manufacturing, and R&D to ensure alignment and readiness.
• Lead root cause analysis and technical problem‑solving throughout the transfer lifecycle.
• Prepare and maintain project documentation, including validation protocols, reports, and change control packages.
• Communicate project progress, risks, and mitigation strategies to stakeholders at all levels.
• Capture and share lessons learned to continuously improve future transfer processes.

What You’ll Need

Success in this role requires technical expertise, attention to detail, and a collaborative mindset. You should be comfortable managing multiple priorities in a fast‑paced, regulated environment.

Required Qualifications

• Bachelor’s degree in engineering, science, or related discipline.
• Minimum of 4 years of experience in medical device manufacturing or other regulated industries.
• Proven track record leading or supporting site or manufacturing transfers; or of new product launches into existing sites.
• Strong knowledge of process validation, change control, and manufacturing documentation.
• Excellent problem‑solving, communication, and organizational skills.
• Ability to work independently and drive results with minimal supervision.

Preferred Qualifications

• Experience with orthopedic implants, instruments, or precision assembly.
• Familiarity with Lean manufacturing and Six Sigma methodologies.
• Proficiency with ERP, PLM, or MES systems.