Principal Mechanical Engineer

Principal mechanical engineers develop new products, redesign existing products, and perform research and testing on product concepts related to medical devices. This individual will be an important member of the Merz Advanced Development team focused on research, development, and bringing to market medical devices to support Merz business objectives. The successful candidate will be involved with projects covering all aspects of advanced development including concept, design, verification testing and transfer to manufacturing. Must have worked in a medical device company and familiar with regulatory and quality requirements throughout all stages of the product development life cycle.

Responsibilities

• Technical Lead:

• Technical leadership of system features and functions as applicable to a medical device. Expectation is this leadership requires collaboration and leading of other engineering groups.

• Mechanical Engineering:

• Take leadership of projects in development, managing all team members assigned to projects to keep them moving forward on schedule.

• Provide engineering analysis, feasibility reports and studies to assist advanced development projects.

• Provide broad mechanical engineering technical expertise through various phases of product life cycle.

• Innovation:

• Develop, design, and test innovative concepts and solutions which align with the needs of the clinic, patient and business.

• Collaborating with the engineering and marketing department on product feasibility.

• Provide mechanical engineering subject matter expertise in designing and building test setups and fixtures for various Advanced Development projects.

• Documentation:

• Maintain accurate documentation throughout the design process per GDP and GMP.

• Write product requirements and specifications to support feature.

• Plan, design, execute and report on system experiments as related to feature development and the product roadmap.

• Test Methods:

• Prove product design by developing test plans, adjusting design, running performance calculations, maintaining quality standards and approve prototypes.

• Validation of the test tool or setup is usually required.

• Prototype manufacturing:

• Lead engineering prototype builds, including generating BOMs, ordering parts and materials, and training lab technicians.

• Work closely with pilot manufacturing line and operations group to develop a device build process.

• Good laboratory practice proficiency:

• Complete knowledge in operating critical lab equipment such as oscilloscope, microscope, acoustic tank, force balance, translation stage, impedance analyzer, pulse-echo fixture, cryostats, and training others.

• Experience testing PCBA and soldering parts

Technical & Functional Skills

• Thorough understanding of test method validation, GR&R, GD&T, and statistical analysis

• Solidworks or other CAD experience

• Understanding and application of ISO Quality System requirements and FDA regulations for medical device manufacturing

• Familiar with a variety of manufacturing processes including mechanical and electromechanical

Minimum Qualifications

• Bachelor's Degree in ME, IE or EE or other relevant Engineering discipline

• 10+ years of related design and manufacturing experience in the medical device and/or component development industry

• Design Control experience including design and process verification and validation.

• Experience in manufacturing and assembly process development and validation (IQ, OQ, PQ)

• Injection molding, die casting, metal stamping and/or machining knowledge, including fixtures gauges and tooling experience

Preferred Qualifications

• Practical knowledge of Six Sigma methodologies or SPC. Green or Black Belt certification

• Familiar with project management methods and tools