Manufacturing Engineer

Manufacturing Engineer

Job Description:

We are seeking a Manufacturing Engineer with at least 2 years of experience in a regulated manufacturing environment, preferably within the medical device industry, to support and enhance manufacturing operations with a strong focus on process validation planning and execution. This role is ideal for an engineer who already has hands-on validation experience and wants to deepen their expertise in medical device process validation while contributing to process development, improvement, and manufacturing scale-up.

Responsibilities:

+ Support and execute process validation activities in compliance with FDA regulations and internal quality requirements.

+ Participate in validation planning by assisting with strategy development, risk assessments, protocol drafting, and planning reviews.

+ Support and execute validation activities, including IQ/OQ/PQ, data collection, data analysis, and preparation of validation reports.

+ Provide a technical perspective during validation planning by reviewing assumptions, approaches, and documentation to ensure robustness and compliance.

+ Apply experience from various validation requirements and manufacturing scenarios to strengthen validation strategies and execution.

+ Assist in planning, executing, and documenting Test Method Validation (TMV) activities to ensure methods are suitable and reliable.

+ Ensure test methods are repeatable, reproducible, and aligned with regulatory expectations.

+ Support process development and continuous improvement initiatives across manufacturing operations.

+ Assist in identifying opportunities to improve process capability, efficiency, and overall manufacturing flow.

+ Apply Lean manufacturing principles or similar methodologies to improve throughput and reduce waste.

+ Assist with manufacturing scale-up activities, including manufacturing flow optimization, capacity analysis, and maximum output and throughput projections.

+ Support readiness for increased production volumes and commercialization of products.

+ Work closely with Manufacturing, Quality, and Engineering teams to execute validation and improvement projects.

+ Collaborate with more engineers as a thought partner, incorporating feedback to strengthen planning and execution.

+ Contribute as an additional reviewer for validation planning and documentation to help ensure quality, completeness, and compliance.

+ Prepare clear, accurate technical documentation and perform data analysis to support engineering decisions and regulatory requirements.

Essential

Skills:

+ At least 2 years of experience in manufacturing engineering within a regulated industry, preferably medical devices.

+ Hands-on experience supporting process validation activities, including planning and execution.

+

Experience with process validation planning and execution, including IQ/OQ/PQ.

+ Exposure to Test Method Validation (TMV).

+ Familiarity with Lean manufacturing concepts and manufacturing flow.

+ Ability to support manufacturing process scale-up, including capacity analysis and throughput projections.

+ Strong technical documentation skills with the ability to write clear protocols, reports, and supporting documentation.

+ Solid data analysis skills to interpret validation and process data and support decision-making.

+ Collaborative mindset with the ability to work effectively with cross-functional teams in Manufacturing, Quality, and Engineering.

Additional Skills &

Qualifications:

+ Bachelor's degree in Engineering, such as Manufacturing, Mechanical, Biomedical, or a related field.

+ Experience in a medical device manufacturing environment or other highly regulated industries.

+ Experience applying Lean manufacturing principles or similar continuous improvement methodologies.

+ Ability to identify and implement process improvements to enhance capability, efficiency, and flow.

+ Interest in building deep expertise in medical device process validation, including both planning and execution.

+ Desire to learn and grow within a regulated environment, leveraging mentoring from experienced engineers.

+ Strong attention to detail and a quality-focused approach to validation and documentation.

+…