OVERVIEW

MY01 Inc. is seeking a highly skilled and experienced Senior Mechanical Developer to play a pivotal role in our regulatory initiatives. The successful candidate will lead the mechanical design and development of MY01’s product. The ideal candidate will demonstrate meticulous attention to detail, adaptability to new environments and challenges, and a commitment to our core values of trust, responsibility, compassion, curiosity, and accountability.
In this role, you will gain valuable experience in a fast-moving, collaborative, and high-performing startup environment while leading a team of highly skilled and knowledgeable individuals. The Senior Mechanical Developer will report directly to the Director of NPI and Sustaining Engineering and will work a total of 40 hours per week.
If you are a motivated and experienced Senior Mechanical Developer professional looking to join a dynamic team at the forefront of medical innovation, we encourage you to apply for the Senior Mechanical Developer position at MY01 Inc.

EXPERIENCE

• M.Sc. or B.Sc. in Mechanical Engineering or a related field.
• Minimum of 7 years of experience in mechanical design and development, preferably in the medical device industry.
• Proven expertise in applying fundamental mechanical engineering principles, including statics, dynamics, mechanics of materials, fluid mechanics, and thermodynamics.
• Strong analytical skills with proficiency in statistical analysis, design of experiments (DOE), and modeling techniques.
• Proficiency in 3D CAD software (preferably Autodesk Inventor), for complex part and assembly design.
• Experience with generating detailed mechanical drawings and GD&T (Geometric Dimensioning and Tolerancing).
• Experience with data analysis tools such as Minitab, MATLAB, Python, or statistical software packages.
• In-depth understanding of various manufacturing processes, including machining, molding, casting, and assembly, with a focus on design for manufacturability (DFM) and design for assembly (DFA).
• Demonstrated ability to apply cost-effective design principles and optimize designs for production efficiency.
• Knowledge of medical device regulations and standards, such as ISO 13485 and FDA guidelines.
• Excellent communication and collaboration skills, with the ability to work effectively in a multidisciplinary team.
• Strong organizational and note-taking skills.
• Ability to multitask and manage multiple complex projects simultaneously.

QUALIFICATIONS

• Baccalauréat ou maîtrise en génie mécanique ou dans un domaine connexe.
• Au moins 7 ans d’expérience en conception et développement mécaniques, de préférence dans l’industrie des dispositifs médicaux.
• Expertise avérée dans l’application des principes fondamentaux de l’ingénierie mécanique, notamment les statistiques, la dynamique, la mécanique des matériaux, la mécanique des fluides et la thermodynamique.
• Solides compétences analytiques avec maîtrise de l’analyse statistique, de la conception d’expériences (DOE) et des techniques de modélisation.
• Maîtrise des logiciels de CAO 3D (de préférence Autodesk Inventor) pour la conception de pièces et d’assemblages complexes.
• Expérience de la production de dessins mécaniques détaillés et de la GD&T (Geometric Dimensioning and Tolerancing).
• Expérience des outils d’analyse de données tels que Minitab, MATLAB, Python ou des progiciels statistiques.
• Compréhension approfondie des différents processus de fabrication, notamment l’usinage, le moulage, la coulée et l’assemblage, avec un accent particulier sur la conception pour la fabrication (DFM) et la conception pour l’assemblage (DFA).
• Capacité avérée à appliquer des principes de conception rentables et à optimiser les conceptions en vue de l’efficacité de la production.
• Connaissance des réglementations et des normes relatives aux dispositifs médicaux, telles que la norme ISO 13485 et les directives de la FDA.
• Excellentes aptitudes à la communication et à la collaboration, avec la capacité de travailler efficacement au sein d’une équipe pluridisciplinaire.
• Solides compétences en matière d’organisation et de prise de notes.
• Capacité à mener plusieurs tâches de front et à gérer simultanément plusieurs projets complexes.

• Lead the mechanical design and development of MY01’s medical devices, including parts, components, and subsystems.
• Generate detailed part drawings and manufacturing plans optimized for cost-effectiveness and efficient production.
• Conduct and lead design reviews, ensuring designs meet functional, regulatory, and manufacturing requirements.
• Collaborate with suppliers to create, assemble, and test functional prototypes, ensuring seamless integration of components.
• Apply design for manufacturability (DFM) principles to ensure products can be successfully transferred to production, focusing on cost reduction and process optimization.
• Demonstrate compliance with applicable medical device standards through verification and validation (V&V) testing.
• Oversee and execute compliance testing for biomedical products, ensuring adherence to safety and performance standards.
• Prepare, review, and publish test protocols, test reports, and complex mechanical analyses.
• Communicate with external test facilities to generate and execute comprehensive testing plans.
• Analyze and process data using advanced statistical analyses and modeling tools to optimize designs and predict performance.
• Serve as a key contributor to product development projects and initiatives, providing technical expertise and guidance.
• Develop tools and jigs for the manufacturing team to improve production efficiency and quality.