Manufacturing Engineer

Sira Consulting, an Inc 5000 company; Plano (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

Sira Consulting, an Inc 5000 company, seeks a Manufacturing Engineer with 3-4 years in medical devices to advance process development, validation and optimization in a fast-paced environment.

You will contribute to process characterization, PFMEA, and DFfM while collaborating across teams to ensure compliance with FDA, ISO 13485, and GMP requirements.

Qualifications

• Minimum 3-4 years in Medical devices - Manufacturing Engineering.
• Experience on Process Validations (IQ, OQ, PQ).
• Experience developing manufacturing processes and technologies, including process characterization.
• Experience working on PFMEAs.
• Experience performing data analysis (Minitab).
• Evaluate process and design alternatives based on Design for Manufacturability principles.

Responsibilities

• 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 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 FDA regulations, ISO 13485, GMP and other regulatory requirements.

Skills

Process Validation

Lean Manufacturing

Design for Manufacturability

PFMEA

Root Cause Analysis

Tools

Minitab

Job description

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)