Urgent! Senior Manufacturing Engineer - Singapore Job Opening In Singapore, Singapore – Now Hiring Maternal Newborn Health Innovations
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
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Unlock Your Senior Manufacturing Potential: Insight & Career Growth Guide
Real-time Senior Manufacturing Jobs Trends in Singapore, Singapore (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Senior Manufacturing in Singapore, Singapore using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 33814 jobs in Singapore and 30247 jobs in Singapore. This comprehensive analysis highlights market share and opportunities for professionals in Senior Manufacturing roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Maternal Newborn Health Innovations is currently hiring and seeking a Senior Manufacturing Engineer Singapore to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Maternal Newborn Health Innovations adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Senior Manufacturing Engineer Singapore Jobs Singapore varies, but the pay scale is rated "Standard" in Singapore. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Senior Manufacturing Engineer Singapore typically include Manufacturing & Production and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Before the Interview:To prepare for your Senior Manufacturing Engineer Singapore interview at Maternal Newborn Health Innovations, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Maternal Newborn Health Innovations's products or services and be prepared to discuss how you can contribute to their success.
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