Lead Mechanical Engineer
vor 1 Monat
Job Overview
Key Responsibilities:
- Oversee the mechanical design, implementation, and validation of devices aimed at the production, assessment, and calibration of high-quality endoscopic instruments.
- Enhance existing machinery through motorization or automation as part of ongoing innovation efforts.
Role and Duties:
- Continuously refine and enhance manufacturing, testing, and calibration processes for endoscopes and their components.
- Work in close collaboration with product and process developers to understand requirements for new products and testing software, ensuring the creation of robust, reliable, and reproducible testing and calibration devices.
- Engage in the design, specification, prototyping, documentation, procurement, qualification, implementation, and enhancement of devices and components for manufacturing, testing, and calibration. Ensure thorough documentation including specifications, validation protocols, assembly instructions, preventive maintenance and calibration (PMC), and manufacturing process instructions (MPIs).
- Assist in product development (R&D) focusing on Design for Manufacturability and Design for Reliability, promoting standardization of hardware and processes.
- Adhere to current Quality Management Systems (QMS), documented operating procedures (DOPs), standard operating procedures (SOPs), and safety regulations.
- Contribute to the ongoing improvement of processes and documentation.
- As part of the project team, your daily tasks will include planning, coordinating, executing, and documenting tests.
- Manage the implementation, commissioning, ramp-up, and acceptance of machinery and equipment.
- Demonstrate a passion for advancing traditional mechanics to meet future challenges.
Qualifications
Essential Knowledge, Skills, and Experience:
- A minimum of 8 years of relevant experience with a Bachelor's degree, or 6 years with a Master's degree; or a doctorate with 3 years of experience; or equivalent professional experience.
- Experience in ISO 9001, or in a regulated environment such as medical device manufacturing.
- Proficient in 3D CAD software (preferably SolidWorks) with extensive experience in mechanical systems.
- Strong expertise in mechanical engineering.
- Solid understanding of sample, prototype, zero-series production, and component/system testing.
- Ability to coordinate development efforts with external partners and suppliers, ensuring alignment across various departments in interdisciplinary projects.
- High proficiency in hardware/software specification and/or systems engineering.
- Familiarity with Rapid Prototyping (Additive Manufacturing) using the Objet Connex 1 PolyJet process.
- Comprehensive knowledge in the design and manufacturability of metal and plastic components.
- Extensive experience with agile project management methodologies (Six Sigma, SCRUM Agile, etc.).
- Proficient in MS Office and open to learning additional software tools (e.g., Polarion, Agile).
- Demonstrated commitment, initiative, strong teamwork abilities, and excellent problem-solving skills.
- Fluent in both German and English, with strong verbal and written communication skills.
- Willingness to travel occasionally for both national and international assignments.
- Prepared to work in a controlled environment, adhering to cleanroom standards including wearing appropriate attire and following hygiene protocols.
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