Company Overview:

Digital Health Solutions is a premier consulting company dedicated to providing comprehensive product development services to medical device companies. Our team of skilled professionals is committed to delivering the highest level of service, ensuring that our clients' products are designed to be safe and effective for their end users.

We are currently seeking a talented Lead Mechanical Engineer to join our dynamic team. The mechanical engineer will be engaged part-time, and will be responsible for early to late-stage device development activities and manufacturing of medical device products.

Responsibilities:

• Lead mechanical design activities for medical devices from concept to commercialization, adhering to regulatory requirements and quality standards.
• Utilize SolidWorks to create detailed design drawings, prototypes, and 3D models.
• Participate in design reviews and assist with dFMEA, pFMEA, and hazard analysis.
• Collaborate with electrical, software, and biomedical engineers to integrate mechanical components into overall system architecture.
• Work closely with manufacturing partners to transition designs into production, providing technical support and troubleshooting as needed.
• Develop of manufacturing and assembly processes and design of manufacturing tools.
• Lead DFM input for product development to enhance manufacturability and optimize product cost.
• Lead design verification and validation activities, including test plan development, protocol execution, and data analysis.
• Stay current with industry trends, emerging technologies, and regulatory updates to inform design decisions and best practices.
• Communicate effectively with clients, project stakeholders, and internal teams to ensure project milestones are met on time and within budget.

Qualifications:

• Bachelor's degree in Mechanical Engineering or related field; advanced degree preferred.
• Minimum of 10 years of experience in mechanical design and development, preferably in the medical device industry or other regulated industries.
• Proficiency with SolidWorks required.
• Experience with Medical Device design and safety standards.
• Excellent problem-solving skills and the ability to work independently or as part of a team.
• Strong communication skills, both written and verbal, with the ability to effectively convey complex technical concepts to non-technical stakeholders.

What We Offer:

• Opportunity to work with cutting-edge technology in the medical device industry.
• A supportive, collaborative work environment that fosters professional growth and development.
• The chance to make a meaningful impact on the safety and effectiveness of medical devices, ultimately improving patients' lives.
• Contract-to-hire opportunity