Senior Engineer, Dynamic Process Engineering

WSA – Wonderful Sound for All; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

WSA – Wonderful Sound for All is seeking a design/engineering professional to lead end-to-end ECR/ECO processes and manage BOMs and drawings for medical devices. You will verify and validate changes, review DFMEA, and coordinate with cross-functional teams to ensure compliant implementation of new designs.

The role requires 3+ years in R&D or product engineering, proficiency with 3D CAD (Creo/SolidWorks), and experience in ISO 13485 environments.

Qualifications

• Minimum 3 years of experience in R&D, Product Design, Process Engineering or Product Engineering.
• Experience in medical devices or electro-acoustic products preferred.
• Experience with ISO 13485, GMP, FDA regulations or similar','Knowledge of ECR/ECO processes and BOM management.

Responsibilities

• Manage end-to-end ECR/ECO process from change initiation to closure and assess impact on BOMs, drawings, and documentation.
• Ensure technical assessments, risk evaluations, verification and validation activities are defined and completed per ECM procedures.
• Review test plans for qualification of new components, materials, supplier process changes, or design changes.
• Review test results and verification/validation data against test plans and address technical issues.
• Review and maintain product BOMs, update drawings/specifications, perform DFMEA, manage obsolescence of BOMs and docs.
• Collaborate with cross-functional and supply chain teams on old stock disposition and rollout of design changes.

Skills

R&D / Product Design

3D CAD (Creo/SolidWorks)

Cross-functional teamwork

English & Mandarin

Education

Bachelor's degree in Mechanical Engineering / Product Design

Tools

PLM

ERP

GD&T software

Job description

Driven by the passion to improve quality of people’s lives, WSA continues to grow as market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation in order to reach more people, more effectively.

What you will do

• Manage and support the end-to-end ECR/ECO process from change initiation through implementation and closure, reviewing engineering changes and assessing their impact on products, BOMs, drawings, specifications, processes and documentation
• Ensure appropriate technical assessments, risk evaluations, verification and validation activities are defined and completed, and that engineering changes are technically justified, properly documented, reviewed and approved per ECM procedures
• Review test plans for qualification of new components, materials, supplier process changes, design hardware changes and alternative or second-source qualification, conducting additional studies where risk assessments are insufficient
• Review test results and verification/validation data against test plans, identifying and following up on technical issues or gaps arising from qualification and verification activities
• Review and maintain product BOMs, update drawings, specifications and related engineering documentation, perform DFMEA to assess design change risk, and manage obsolescence of BOMs, drawings and specifications
• Participate with cross-functional and supply chain teams on old stock disposition and the rollout of new design changes, updating the DMR for the manufacturing process and monitoring change implementation to ensure approved changes are accurately incorporated.

What you bring

• Minimum 3 years of experience in R&D, Product Design, Process Engineering or Product Engineering, with a university degree in Mechanical Engineering, Product Design, Mechanical Design, Product Engineering or a related discipline
• Experience in medical devices, hearing aids, wearable electronics, consumer electronics or electro-acoustic products is highly preferred
• Experience with PLM, ERP and Quality Management Systems, along with knowledge of ISO 13485, GMP, FDA regulations or other regulated manufacturing environments
• Experience with Engineering Change Management, ECR/ECO processes, BOMs, engineering drawings and product documentation, and working with cross-functional teams in a manufacturing or product development environment
• Proficient in 3D CAD software such as Creo, SolidWorks or equivalent, with good knowledge of 2D engineering drawings, GD&T, tolerances and material specifications

Understanding of plastic injection moulding, tooling, machining and other relevant manufacturing processes, with good understanding of BOM structures and product configurations; fluent English, with Mandarin also required

Who we are

At WSA, we provide innovative hearing aids and hearing health services.

Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.

With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.

Sounds wonderful? We can't wait to hear from you.

WSA is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.