layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Senior Mechanical Design Engineer at Cala Health

Mechanical Design Leadership: Lead mechanical design and reviews, managing complex schedules and technical requirements throughout the development process.
Prototyping & Testing: Design high-fidelity prototypes to facilitate usability studies and requirements characterization.
Verification & Validation: Define comprehensive testing plans, develop custom test methods and fixtures, and lead final product mechanical verification activities.
Lifecycle Management: Support design control documentation and lead engineering change orders (ECOs) to maintain product documentation and integrity.
Manufacturing & Sustaining: Drive manufacturing transfers and partner with production teams to identify, propose, and implement continuous improvements.
Quality Compliance: Diagnose, document, and support Cala’s Quality Management System, including any NCMRs and CAPAs related to mechanical design.
Skills and Experience
We are looking for a Senior Mechanical Design Engineer to support product development in a dynamic, fast-paced startup environment, exemplified by:
Education: BS in Mechanical Engineering or a related technical field.
Technical Expertise: 5+ years of experience in mechanical engineering, with a strong focus on electromechanical systems and early clinical study support.
Practical Experience: Has taken a Class II medical device all the way from initial design through FDA 510k approval and transfer to manufacturing for commercialization. Experience with wearables or high-touch consumer electronics design a plus.
Manufacturing Fluency: Design for Manufacturing (DFM) mindset, including knowledge of diverse processes including: plastic injection molding, silicone molding, machining, PCB fabrication/assembly, and 3D printing. Experience working with Contract Manufacturing partners to smoothly transfer development activity into production environment.
Advanced CAD: Expert-level SolidWorks skills, specifically with complex surfacing, manufacturability, and tolerancing.
Regulatory Knowledge: Familiarity with medical device standards, such as IEC 60601-1 (safety/essential performance) and ISO 10993 (biocompatibility).
Quality & Rigor: Demonstrated experience with medical device phase-gate development, risk analysis, design control practices, and root cause analysis.
Analytical Skills: GD&T, proficiency in statistical analysis (such as DOE) to inform design decisions and verification results.
Applicants must be authorized to work in the United States on a full-time basis, or eligible for work authorization through a sponsorship path that Cala Health is able to support. Sponsorship decisions are made individually based on role, timeline, and cost considerations, and are not guaranteed.
Cala Health believes our success is based on diversity of people, teams and thinking. We offer all employees the tools, training and mentoring they need to succeed. Our selection process is driven by the key requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-jobrelated disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Senior Mechanical Design Engineer

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