Senior Manufacturing Engineer

Overview

The Senior Manufacturing Engineer is responsible for leading critical initiatives to develop, setup and qualify manufacturing processes for OdonAssist, ensure compliance with regulatory standards, and drive innovation in our product development efforts. As a key member of the MNHI Technical team, the senior manufacturing engineer will also be involved in maintaining and enhancing the quality, efficiency and scalability of our manufacturing operations. This is an individual contributor role, part of the Engineering team and reporting to the VP of Engineering and Manufacturing. This is a new position and the first one in our small team that will be fully dedicated to manufacturing.

• Lead the collaboration with external vendors and contract manufacturers to define and develop manufacturing equipment and processes for Class I and II products. This includes process characterization, equipment buy-off, validation, and scale-up activities in compliance with ISO 13485 and FDA regulations (21 CFR Part 820).

• Evaluate and enhance existing manufacturing processes to improve efficiency, yield, and cost-effectiveness while maintaining product quality and regulatory compliance for existing products.

• Lead initiatives to implement new technologies, processes and materials to advance manufacturing capabilities and reduce costs.

• Lead root cause analysis and implement corrective/preventive actions (CAPA) to address manufacturing issues or manufacturing related product complaints to prevent recurrence.

• Collaborate with contract manufacturers to develop and review manufacturing procedures, work instructions and other manufacturing documents.

• Close collaboration with cross functional team from Quality Assurance, Supply Chain, Regulatory Affairs and contract manufacturers to ensure product and process integrity throughout the product life cycle.

• Drive continuous improvement initiatives using Lean, Six Sigma, or other methodologies to optimize processes and eliminate waste.

• Collaborate closely with Engineering team, contract manufacturers and external vendors to ensure seamless transfer of new products into manufacturing.

• Support new product introduction through Design for Manufacturability (DFM), process development and production readiness.

• Ensure contract manufacturers and external vendors implement best practices and compliance with international EHS (Environment, Health & Safety) requirements.

• Requires a Bachelor’s Degree in Engineering (Mechanical, Biomedical or Industrial) with minimum 6-10 years of progressive experience within the medical devices industry (ISO 13485, FDA) with a strong background in manufacturing line setup, process development and optimization, equipment and process validation.

• Lead collaboration with contract manufacturers for at least one manufacturing line setup, process development and optimization, equipment and process validation for Class I or II medical devices.

• Good knowledge and experience with various manufacturing processes eg. automation, semi-automation, assembly, injection molding, extrusion, blow molding, leak tester, packaging sealing, ultrasonic welding, UV adhesive curing etc.

• Develop manufacturing processes for medical devices using methodologies such as Design Thinking, DFM and DFSS techniques.

• Hands-on experience with equipment qualification and buy-off of manufacturing equipment with contract manufacturers.

• Hands-on experience with process validation, test method validation (MSA, GR&R), risk management with responsibility in developing process FMEA, root cause analysis and CAPA.

• Leading and collaborate with cross-functional and international teams from different cultures, locations and time zones.

• Excellent analytical and problem-solving skills, with a strategic mindset and a focus on continuous improvement.

• Strong interpersonal skills with excellent communication skills both orally and in writing. Fluency in English and Mandarin is essential.

• Able to travel internationally and out station at contract manufacturers for period of time.

• Able to influence or drive external vendors or contract manufacturers to meet timeline and deliver positive outcomes.

• Able to prepare protocols and reports for qualifications, validation and testing is essential.

• Certification in statistical analysis, Lean or Design for Six Sigma (Green Belt or Black Belt) with ability to use Minitab (or equivalent system) is desirable.

• Experience in project management is a plus.

• Passionate about the MNHI purpose and embraces the MNHI values of inclusivity, teamwork, and personal responsibility