Manufacturing Engineer with Medical device

Akshar Staffing; Plano (TX); On-site; USD 85,000 - 110,000; Full time

Job summary

Akshar Staffing is seeking a Manufacturing Engineer for the medical devices sector in Plano, TX. The role requires a Bachelor's in mechanical or manufacturing engineering and 3–4 years of relevant experience, focusing on process validation and manufacturing development.

Responsibilities include process characterization, PFMEA, data analysis with Minitab, and implementing DFM principles. Strong communication and teamwork are essential in a fast-paced environment with FDA/ISO compliance.

Qualifications

• Minimum 3–4 years of experience in medical devices manufacturing engineering.
• Experience on Process Validation (IQ, OQ, PQ).
• Experience developing manufacturing processes and process characterization.
• Experience with PFMEAs.
• Data analysis experience using Minitab.
• Evaluate process and design alternatives using DFM principles.
• Ability to work both in a team and independently in a fast-paced environment.
• Strong written and verbal communication across organizational levels.
• Multitask, prioritize, and meet deadlines with attention to detail.
• Complies with FDA regulations, ISO 13485, GMP and company procedures.

Skills

Manufacturing process development

Optimization

Lean Manufacturing

FMEA

Root cause analysis

Tooling & fixtures

Design for Manufacturability

Production troubleshooting

Quality systems knowledge

Education

Bachelor's degree in mechanical engineering or manufacturing engineering

Tools

Minitab

Job description

Position: Manufacturing Engineer with Medical device

Job Summary:

Qualification: Bachelors in mechanical engineering or manufacturing engineering or equivalent

Minimum experience of 3-4 years in medical devices - Manufacturing Engineering.

• Good Experience working on Process Validations (IQ, OQ, PQ)
• Experience developing manufacturing processes and technologies, which includes process characterization
• Experience working on PFMEAs
• Experience performing Data analysis (Minitab)
• Evaluate process and design alternatives based on Design for Manufacturability principles.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Skill:

1. Manufacturing process development and optimization
2. Lean Manufacturing and Continuous Improvement
3. Process Validation and FMEA (Failure Mode & Effects Analysis)
4. Root Cause Analysis and Problem Solving
5. Tooling, fixture, and equipment design
6. Design for Manufacturability (DFM)
7. Production troubleshooting and equipment support
8. Quality systems knowledge (FDA, ISO 13485, GMP)