- 경험
- 6~10세
- 샐러리
- —
- 채용 공고
- 1
- 게시됨
- 3시간전
- 작업 모드
- 사무실에서
- 교육
- Bachelors in Engineering or Masters in Engineering
- 적임
- Applicants should be experienced engineering professionals with a background in medical device process design or equipment engineering, relevant engineering qualifications and the ability to work in an English-speaking, multicultural environment.
- 재개하다
- 신청 시 필수 사항
당신이 일하게 될 곳
직무 설명
About Linxens
Linxens is an international specialist in micro-connectors, module packaging, antennas and inlays, as well as secure ID technologies. With more than four decades of innovation, the company is headquartered in Paris, France, and operates R&D and manufacturing facilities across Germany, France, Sweden, China, India, Singapore and Thailand.
Its solutions support a wide range of industries, including telecom, finance, transportation, hospitality, e-government, healthcare and the Internet of Things (IoT). Linxens places strong emphasis on employee development, continuous learning and long-term career growth, as its business expansion creates new opportunities.
Role Summary
The Process Design Engineer / Equipment Engineer will contribute to early-stage project planning, define equipment and process requirements, and help drive the design, sourcing, validation and industrialization of manufacturing solutions in a regulated medical device environment.
Project Planning and Timeline Definition
- Support projects, pre-projects and exploratory studies by helping shape plans, gather needs and translate them into equipment specifications.
- Set up the engineering work plan for equipment and process design, ensuring tasks are aligned with quality and engineering expectations so delivery stays on schedule.
Equipment and Process Design, Installation and Validation
- Own the design, development and integration of equipment while meeting ISO 13485 requirements and other applicable regulations.
- Assess manufacturing approaches and confirm they match product needs and production objectives.
- Identify gaps in technology, workforce readiness and capability to support a successful move into production.
- Carry out risk assessments and determine the key factors needed for successful equipment and process deployment.
- Prepare technical needs, business justifications and CAPEX proposals for new equipment and process investments.
- Create equipment specifications, manage supplier shortlisting and selection, evaluate tenders and support purchase order decisions.
- Run internal and external design reviews and manage investment initiatives using structured project management methods.
- Oversee qualification and validation work such as FAT, SAT, IQ and participation in process validation activities.
Prototyping and Industrialization Support
- Track new technologies and equipment developments relevant to the market.
- Build and improve prototyping capabilities that support R&D and innovation efforts.
- Help move solutions from prototype stages into stable industrial production.
Qualifications
- 6 to 10 years of experience in process design or equipment engineering within the medical device industry.
- A Bachelor’s or Master’s degree in Engineering, preferably Mechanical, Industrial or a closely related discipline.
- Practical background in process design, equipment sourcing, commissioning, qualification and technical documentation.
- Strong understanding of process validation activities, including IQ, OQ and PQ, along with ISO 13485.
- Excellent communication skills and the ability to manage stakeholders effectively.
- Fluency in English is required.
Additional Information
This is a full-time onsite role based in Changi, East Region, Singapore.
Linxens describes itself as an equal-opportunity employer and states that it does not tolerate unlawful or unethical discrimination. Through its CSR Vitality program, it commits to recruiting, hiring, training, compensating and promoting people without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, physical or mental disability, marital status or any other legally protected characteristic.
Who Can Apply
Professionals with the required medical device process design or equipment engineering background, relevant engineering education and strong English communication skills are suitable for this role.