SUMMARY:                                                                                                                               

The Senior Project Engineer, LifeSync Source serves as the primary technical liaison between LifeSync’s contract manufacturing customers and the internal engineering and manufacturing teams at LifeSync’s facilities in China and Florida. This customer-centric role requires a strong technical foundation in medical systems using medical cables and a deep understanding of LifeSync’s manufacturing and design capabilities.

The Senior Project Engineer collaborates with cross-functional teams - including Sales, Project Management, R&D, Manufacturing Engineering, Quality, and Regulatory Affairs - to develop and optimize product designs that meet customer requirements for performance, quality, cost, and regulatory compliance. Responsibilities span the entire product lifecycle, from new product development to sustaining engineering and line extensions.

Success in this role requires a structured, detail-oriented mindset, strong mechanical and electrical design skills, and the ability to execute multiple projects simultaneously. Prior experience in medical device product development and technical documentation is essential.

DUTIES AND RESPONSIBILITIES:

Customer Collaboration & Technical Leadership

• Serve as the primary technical point of contact for customers, ensuring clear communication of design, quality, and regulatory requirements.
• Work with customers to define and document product specifications, design constraints, and verification/validation (V&V) needs.
• Facilitate customer requirements for prototypes and align on V&V strategies to support regulatory submissions and product launch.
• Assist customers with design reviews, risk management activities, and regulatory compliance requirements.
• Provide technical expertise to support sales efforts, customer engagements, industry conferences, and exhibitions.

Product Design & Development

• Brainstorm and refine design solutions with customers and internal R&D teams.
• Develop mechanical and electrical designs while ensuring compliance with industry standards and best practices.
• Conduct worst-case tolerance analyses for components and subassemblies to ensure robust designs.
• Work with LifeSync Manufacturing Engineering and customer teams to optimize designs for manufacturability, cost efficiency, and reliability.

Risk Management & Quality Compliance

• Contribute to risk management activities, including risk hazard analysis, dFMEA, and pFMEA.
• Support customer complaint investigations, including root cause analysis, and implementation of corrective actions for design, process, or supplier quality issues.
• Participate in internal and external design reviews throughout the product development process.

 Project Execution & Documentation

• Assist LifeSync’s project management function in developing structured project plans, including scoping, work breakdown structures, Gantt charts, risk registers, and status reports.
• Review and contribute to test protocols and reports, ensuring alignment with industry standards and quality system requirements.

 Innovation & Continuous Improvement

• Identify opportunities for innovation and intellectual property (IP) creation.
• Support process improvements in design, manufacturing, and quality control.
• Collaborate with teams to implement best practices in design for manufacturability (DFM) and design for reliability (DFR).

 REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

 Technical Expertise & Design Skills

• Proficiency in technical communication, including structuring and presenting technical information for internal and external audiences.
• Strong interpretation skills for drawings, specifications, mechanical, electrical, and material requirements.
• Experience in CAD solid modeling, such as using SolidWorks.
• Experience in the design and manufacture of custom molded parts, injection over-molding, and printed circuit board assemblies.
• Proficiency in design for manufacturability (DFM) and manufacturing process development.
• Strong technical writing skills, including preparation of design documentation, test reports, and risk management documentation.
• Experience in project management methodologies, including work breakdown structures, risk registers, and execution status reporting.

 Regulatory & Compliance Knowledge

• Familiarity with FDA QSR, ISO 13485, and regulatory design controls.
• Expertise in product risk management, including risk hazard analysis, dFMEA, and pFMEA.
• Knowledge of common medical device industry design and manufacturing standards, such as IEC 60601-1, ISO 14971, and IPC standards.

 General & Soft Skills

• Strong problem-solving skills, with the ability to balance technical, quality, and business considerations.
• Ability to be flexible with working hours to accommodate global time zones.
• Excellent communication and interpersonal skills, with the ability to gain buy-in from customers and internal stakeholders.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, MS Project preferred).
• Strong understanding of component and BOM structures within ERP systems. 

SUPERVISORY RESPONSIBILITIES: N/A

EDUCATION AND/OR EXPERIENCE:

• Bachelor’s degree in mechanical engineering, Biomedical Engineering, Electrical Engineering, or a related discipline.
• 5 years of experience in design engineering, with at least 2 years in a regulated industry (medical devices preferred).
• 2 years of experience working directly with external customers in a technical role.

PHYSICAL DEMAND: 

Physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Stand, move, sit, talk/hear, vision, lift to ≤10 lbs. 

WORK ENVIRONMENT:

Typical Office / Production Environment

TRAVEL REQUIREMENT:

• Domestic: typically, once per month (or less).
• International: typically, once per year.

LifeSync provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

The Age Discrimination in Employment Act (ADEA) forbids age discrimination against people who are age 40 or older. It does not protect workers under the age of 40, although some states have laws that protect younger workers from age discrimination. It is not illegal for an employer or other covered entity to favor an older worker over a younger one, even if both workers are age 40 or older.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.