Business Area: Production- Employment type: Full-time**Responsibilities**:
- Regulatory: FDA, ISO, GMP, TPS, DOT, ASME.
- Experienced engineer with more than 4+ years focused to provide highly valuable and practical solutions that focus on high-quality product designs with reduced manufacturing costs.
- Medical device experience / Medical device production lines transfers.
- Engineer Process Development / Project lead.
- Developing tooling and manufacturing processes, by studying product requirements; researching, designing.
- Test and equipment validation to ensure compatibility with the product and process method, providing efficiency, as well as cost-effectiveness; missioning company priorities and end-users needs.
- Regulatory: FDA, ISO, GMP, TPS, DOT, ASME.
- Manage the portfolio of Productivity Projects including Value engineering and component engineering, including metrics of performance
- Influence and drive the program evolution from ideas to final delivery to production
- Support initiatives like resiliency and obsolescence
- Support engineering team to resolve project blockers
- Analysis of risk, and ability to articulate clear escalation request when needed or when project is impacted of materialized risks.
- work in a matrix environment across multiple stakeholders comprised of development team offering managing, manufacturing, regulatory, quality, sourcing and management to achieve Fire productivity business goals.
**Qualifications**:
- BE/BS bachelor's degree
- Communication skills
- 4+ years of medical devices experience. Or +2 years in experience in NPI, and/or product life cycle management
- Test methods development and validation
- Advanced English.
- Lean and Six Sigma skills
- Knowledge in FDA
- Knowledge of Agile metrics and usage of the performance indicators.
- Experience as a group leader or people manager
- Knowledge of regulatory standards
- Ability to create and present status report when needed, highlighting the impact of external risk factors.
**Work Environment**
This is a manufacturing facility and as a result employees have the potencial to be exposed to noise chemical, fumes, arboine paticl, mechinery, vribrations or thoer workplace hazards controlled within compliance of current safety and health standards.
**How to Apply**
**About Ambu**:
Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.