制造工程师
1.5-2.5万上海市本科不限经验
职位描述
PURPOSE OF THE ROLE
The Manufacturing Engineer, also known in some businesses as a New Product Introduction – (NPI) Engineer, is responsible for transitioning, and facilitating new medical devices, variants, or improvements from product development into a manufacturer and commercially viable form. Its greatest benefit to business is developing the supply chain’s ability to translate designs into a manufacture form which is typically a bottleneck implementing new products, or resolving field issues and when not done well, ultimately results in poor customer responses and delays. It serves both a short- and long-term outlook for implementing any new product or variant.
The Manufacturing Engineer works directly with the supply chain, R&D and Breas manufacturing stakeholders. They need to consider robust mass manufacturing processes and be directly involved with DFM, tool design, moulding requirements, process qualifications, work instructions, production ramp up, and operate within Breas quality requirements, timelines, and budgets.
Where sustaining engineering needs are required, the Manufacturing Engineer leads and expedites responses to assist in implementation of resolution from redesign to the internal customers.
Breas emphasizes team members follow the principles of One Team, Ownership, and Courage.
RESPONSIBILITIES
Collaboration
1.Execute Product Development and Technology Development manufacturing programs balancing Quality, Time and Cost to achieve stated business outcomes within a highly collaborative team
2.Manage collaboration between our supply partners, assist in identifying new or key suppliers, assess new supplier capability, and the technical R&D team to build robust and reliable manufacturing capability
3.Collaborate with internal stakeholders to ensure XFT requirements are met.
New Product Introduction (NPI)
1.Translate R&D concepts into manufacturable designs using DFM/DFA principles
2.Lead pilot builds and transfer-to-manufacturing activities
3.Provide cost benefit analyses for different solution options.
4.Participate in or lead design reviews.
5.Collaborate with suppliers to define and optimize parameters, cycle times and materials for new products within Breas Quality expectations.
6.Develop and execute process development plans, including risk assessments and control strategies
7.Drive process validation (IQ/OQ/PQ) and ensure compliance with ISO 13485 and FDA QSR
Sustaining/Lifecycle Engineering
1.Troubleshoot process issues and implement corrective actions
2.Support root cause analysis and continuous improvement initiatives
3.Assess and qualify new suppliers for injection and silicone moulding processes
4.Collaborate with suppliers to optimize tooling, process controls, and scalability
MINIMUM KEY REQUIREMENTS
Listing the knowledge, skills, and experience or education required for a position makes it clear to candidates whether they have the necessary qualifications for a position.
Mandatory
1.Minimum 5 years in injection moulding processes (Plastic and LSR moulding preferred)
2.Minimum 5 years in Design For Manufacturing (DFM) experience
3.Understanding of Process qualification principles and production process risk management
4.Ability to conduct statistical analysis to determine acceptable quality levels based on industry standards
5.Excellent verbal and written communication – Synthesizing complex engineering findings into actionable findings for broader business stakeholders
6.Must speak fluent Mandarin and English
7.Demonstrated ability to balance Quality, Time and Cost to resolve technical problems robustly whilst achieving business outcomes
8.3D CAD experience – Solidworks preferred (DFM review only)
9.Design for manufacturing DFM knowledge, Lean manufacturing
10.Knowledge in polymer, silicone part design for manufacturing and Injection moulding
11.Minimum basic knowledge in plastic tooling design and features
12.Demonstrated strong problem-solving capability using structured industry method
Optional
1.Familiarity with ISO13485 or Experience in another highly regulated industry preferred
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