Position Summary
The Personalized Solutions team provides patient-specific devices for complex clinical cases, such as oncology, where no other device exists on the market. These devices are prescribed by physicians and comply with all relevant laws for single-patient use. As a Precision Engineer, you will establish best-in-class manufacturing processes, deliver results independently or as part of a team, and support other departments with technical expertise. You will manage your caseload under tight deadlines and assist in process development for various implant types, ensuring proper cleaning, packaging, and adherence to Quality and Regulatory procedures. Some work outside normal hours may be required.
What you will do:
1. Collaborate with Engineering leaders to meet business objectives.
2. Develop and implement documentation, SOPs, and work instructions in line with GMP standards.
3. Lead technical improvements through the Continuous Improvement Program (CIP).
4. Perform detailed First Article Inspections of products such as implants, guides, models, and instruments.
5. Inspect vendor and internally manufactured implants for development and investigation.
6. Generate CAD drawings and apply GD&T principles according to ASME Y 14.5M 1994 (R 2004).
7. Work closely with the Design Department on the design and inspection of complex medical device components.
8. Support manufacturing activities, ensure safety and quality compliance, and promote efficiency.
9. Enhance productivity and reduce waste using advanced inspection techniques.
10. Engage in engineering and metrology research, exploring new inspection systems and technologies.
11. Analyze inspection data, perform Gage R&R studies, and optimize process parameters.
12. Program, debug, and validate complex inspection equipment, often requiring long programming sessions.
Candidate requirements:
* Experience inspecting components from engineering drawings and 3D CAD models in a production setting.
* Formal Mechanical or Manufacturing Engineering qualification or equivalent experience.
* Ability to program, set up, and operate inspection machines like CMMs.
* Experience with offline 3D inspection programming (e.g., MCOSMOS).
* Knowledge of work holding, probing, quality standards, and time management.
* Commitment to safety and good housekeeping.
* Ability to work independently under pressure and as part of a team.
* Excellent verbal and written communication skills.
* Proficiency with MS Windows applications.
* Flexible, results-driven, self-motivated, with a proactive approach.
* Ability to identify and implement improvements.
* Desire for role progression.
* Experience with CNC machining (turning/milling).
Minimum Qualifications:
* Level 7 Degree in Mechanical Engineering or equivalent.
* 2-4 years of experience with CNC or CMM machines.
Preferred Experience:
* Strong communication and influencing skills.
* Leadership capabilities to guide engineers, technicians, and operators.
* Ability to work in a multidisciplinary, fast-paced environment.
* Analytical, problem-solving, and process improvement skills.
* Excellent presentation and communication skills.
* Autonomous working ability.
* Team-oriented with a flexible approach.
* Willingness to adopt new technologies and automation.
* Confident decision-maker with leadership qualities.
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