Sr. Manufacturing Engineer - Medical Device

TekHawks; Kalamazoo (MI); On-site; USD 85,000 - 120,000; Full time

Job summary

TekHawks in Kalamazoo, Michigan, seeks a Senior Manufacturing Engineer with a strong mechanical background to support our medical device engineering team. The role requires 2–4 years of hands-on manufacturing experience and the ability to work closely with engineering, quality, and operations to improve reliability and manufacturing processes.

You will drive process development, validation, and continuous improvement initiatives while ensuring compliance with FDA QSR, ISO 13485, and related

Qualifications

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or related field.
• 2–4 years of relevant manufacturing engineering experience.
• Strong mechanical engineering fundamentals.
• Hands-on experience in a manufacturing or production environment.
• Experience troubleshooting manufacturing processes and equipment.
• Experience supporting engineering builds and manufacturing activities.
• Experience with validation, testing, or process qualification activities.
• Working knowledge of IQ/OQ/PQ and quality systems (FDA QSR, ISO 13485).
• Experience with statistical analysis, Cp/Cpk, and SPC.
• Exposure to risk management tools (FMEA).
• Strong analytical and problem-solving skills.
• Ability to work collaboratively in a cross-functional team.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Experience in a regulated medical devices environment.

Responsibilities

• Support manufacturing engineering activities within a medical device manufacturing environment.
• Provide hands-on engineering support within the manufacturing environment.
• Support engineering builds, manufacturing activities, and production-related troubleshooting.
• Investigate manufacturing issues and develop practical mechanical solutions.
• Support process development, optimization, and improvement activities.
• Assist with validation activities, including protocol execution, data collection, documentation, and reporting.
• Support reliability improvement efforts and identify opportunities to improve process consistency and product performance.
• Participate in engineering studies, testing, and data analysis.
• Assist with root cause investigations and implementation of corrective actions.
• Develop and maintain manufacturing documentation, work instructions, reports, and other engineering documentation.
• Interpret engineering drawings, specifications, and manufacturing requirements.
• Support continuous improvement initiatives related to quality, cost, efficiency, and manufacturability.
• Work closely with cross-functional teams to ensure technical activities stay on schedule.
• Provide technical support across multiple manufacturing engineering activities as priorities evolve.
• Communicate technical findings, risks, and recommendations to engineering and project leadership.
• Ensure work is completed in accordance with applicable quality systems and medical device requirements.

Skills

Strong mechanical fundamentals

Hands-on manufacturing experience

Cross-functional collaboration

Analytical problem-solving

Effective communication

Multitasking in fast-paced environment

Education

Bachelor's degree in Mechanical Engineering

Tools

CAD software

Statistical analysis (SPC/DoE)

Job description

Client is seeking a Senior Manufacturing Engineer with a strong mechanical

engineering background to support our growing medical device engineering team in Kalamazoo, Michigan.

The ideal candidate will have 2–5 years of hands‑on manufacturing engineering experience, strong mechanical fundamentals, and the ability to work effectively in a manufacturing environment. This role will work closely with engineering, manufacturing, quality, and operations teams to execute technical activities, improve reliability, and support manufacturing processes.

Responsibilities:

• Support manufacturing engineering activities within a medical device manufacturing
• Provide hands‑on engineering support within the manufacturing environment.
• Support engineering builds, manufacturing activities, and production-related troubleshooting.
• Investigate manufacturing issues and develop practical mechanical solutions.
• Support process development, optimization, and improvement activities.
• Assist with validation activities, including protocol execution, data collection, documentation, and reporting.
• Support reliability improvement efforts and identify opportunities to improve process consistency and product performance.
• Participate in engineering studies, testing, and data analysis.
• Assist with root cause investigations and implementation of corrective actions.
• Develop and maintain manufacturing documentation, work instructions, reports, and other engineering documentation.
• Interpret engineering drawings, specifications, and manufacturing requirements.
• Support continuous improvement initiatives related to quality, cost, efficiency, and manufacturability.
• Work closely with cross‑functional teams to ensure technical activities remain on schedule.
• Provide technical support across multiple manufacturing engineering activities as priorities evolve.
• Communicate technical findings, risks, and recommendations to engineering and project leadership.
• Ensure work is completed in accordance with applicable quality systems and medical device requirements.

Requirements:

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline.
• 2–4 years of relevant manufacturing engineering experience.
• Strong mechanical engineering fundamentals.
• Hands‑on experience working in a manufacturing or production environment.
• Experience troubleshooting manufacturing processes and equipment.
• Experience supporting engineering builds and manufacturing activities.
• Experience with validation, testing, or process qualification activities.
• Working knowledge of process validation (IQ/OQ/PQ) and quality systems (e.g., FDA QSR, ISO 13485)
• Experience with statistical analysis, process capability (Cp/Cpk), and SPC
• Exposure to risk management tools (e.g., FMEA)
• Strong analytical and problem‑solving skills.
• Ability to work collaboratively in a cross‑functional team environment.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities within a fast‑paced environment.
• Experience working within a regulated industry, preferably medical devices.

Preferred:

• Medical device manufacturing experience.
• Experience with process validation and qualification.
• Experience with reliability testing or reliability improvement initiatives.
• Experience with Design for Manufacturability (DFM).
• Experience with root cause analysis and corrective actions.
• Experience with manufacturing process development and continuous improvement.
• Familiarity with FDA-regulated manufacturing environments and quality systems.
• CAD experience and the ability to interpret mechanical drawings.
• Experience with statistical analysis, DoE, or engineering studies.

What Success Looks Like

Success in this role will mean providing strong technical manufacturing engineering support while helping improve reliability, quality, and manufacturing performance.

The Senior Manufacturing Engineer will be a hands‑on contributor who can identify manufacturing challenges, develop practical solutions, support validation and reliability activities, and work effectively across the engineering and manufacturing organizations.

This is an onsite, hands‑on engineering role located in Kalamazoo, Michigan.