Product Development Engineer II

Job Description

Job Description

Job Title:

Product Development Engineer II

Department:

Design Engineering

Reports to:

Design Engineering Manager

FLSA

Exempt

SUMMARY:

The Product Development Engineer II is responsible for the technical execution of engineering activities supporting the development, modification, verification, commercialization, and lifecycle management of medical device products.

This position applies engineering principles, analytical thinking, and structured problem-solving to evaluate product designs, investigate technical issues, formulate and document specifications, develop and execute verification activities, and ensure engineering deliverables are technically sound, accurate, and compliant with applicable Design Controls and Quality Management System requirements.

The position works cross-functionally with Engineering, Manufacturing, Quality, Regulatory Affairs, and other functions to support product development and sustaining engineering activities. The Product Development Engineer II independently executes assigned engineering activities and work packages, exercising engineering judgment within established requirements and seeking guidance from senior engineering personnel for broader technical direction and complex design decisions.

Essential Responsibilities:

• Execute engineering activities supporting new product development, product modifications, line extensions, and sustaining engineering in accordance with established project requirements and Design Controls.
• Apply engineering principles, analytical thinking, and structured problem-solving to evaluate product designs, materials, components, manufacturing processes, and product performance.
• Develop and evaluate design concepts and technical solutions within established product requirements and project objectives, and prepare product specifications, drawings, Bills of Material (BOMs), and other engineering documentation.
• Perform engineering analyses, including tolerance analysis, technical trade-off evaluations, failure analysis, and interpretation of product and test data.
• Develop and maintain Design History File (DHF) documentation, including design inputs and outputs, traceability, verification and validation documentation, and supporting technical evidence.
• Develop and execute design verification protocols and support design validation activities; analyze and interpret test data and prepare technically sound reports demonstrating compliance with applicable requirements.
• Participate in product risk management activities, including hazard analysis and FMEA, and provide engineering analysis to identify and evaluate appropriate risk controls.
• Participate in design reviews by providing technical analysis, test data, and recommendations and identifying potential technical risks or design deficiencies.
• Collaborate with Manufacturing Engineering and Operations to support Design for Manufacturability (DFM), prototype and pilot builds, process validation, design transfer, and production implementation.
• Evaluate engineering changes for technical, product performance, manufacturing, quality, risk management, and regulatory impacts and prepare appropriate change documentation.
• Support investigations of product failures, customer complaints, nonconformances, and CAPAs using structured root cause analysis and recommend technically justified corrective actions.
• Ensure assigned engineering activities and documentation are complete, accurate, traceable, and compliant with applicable FDA Design Controls, ISO 13485, ISO 14971, LifeSync's Quality Management System, and applicable technical standards.
• Support preparation of technical evidence for regulatory submissions and technical documentation, including FDA 510(k) and EU MDR requirements, as applicable.
• Work collaboratively with Engineering, Manufacturing, Quality, Regulatory Affairs, suppliers, test laboratories, and other functions while independently executing assigned engineering responsibilities.

Required Qualifications:

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related engineering discipline.
• Minimum 3 years of relevant engineering experience, preferably involving product design and development in a regulated industry.
• Demonstrated ability to apply engineering principles, analytical thinking, data analysis, and structured problem-solving to product design, testing, failure investigation, and technical decision-making.
• Experience developing and executing engineering test methods or protocols, analyzing and interpreting test data, and documenting technically sound conclusions.
• Working knowledge of structured product development processes, including design requirements, verification and validation, design reviews, risk management, and engineering changes.
• Ability to interpret engineering drawings, specifications, material requirements, and applicable technical standards.
• Experience preparing clear, accurate, and traceable engineering documentation, including specifications, protocols, reports, and design records.
• Experience with CAD solid modeling, preferably SolidWorks.
• Understanding of Design for Manufacturability (DFM) and the interaction between product design and manufacturing processes.
• Strong written and verbal communication skills and demonstrated ability to work effectively within cross-functional teams.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.

Preferred Qualifications:

• Working knowledge of FDA Design Controls, ISO 13485, ISO 14971, and applicable medical device technical standards.
• Experience applying recognized medical device standards (e.g., IEC 60601 series, ISO 10993, ASTM D4169, ISTA distribution standards, or similar) during product development, verification, validation, and product commercialization.
• Hands-on experience with product prototyping, verification testing, failure analysis, and root cause investigation.
• Experience supporting design transfer and new product introduction.
• Experience with engineering change control, CAPA, nonconformance, or customer complaint investigations.
• Familiarity with FDA 510(k), EU MDR Technical Documentation, or other medical device regulatory submission requirements.
• Experience with ERP and/or product data management systems.
• Experience working with contract manufacturers and supplier development.

SUPERVISORY RESPONSIBILITIES:

This is an individual contributor role with no supervisory responsibilities.

PHYSICAL DEMAND:

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

Stand, move, sit, bending (neck), bending (waist), stoop, kneel, talk, hear, hand use: dominant hand (right/left), repetitive use of hand, simple grasping with left and right hand, power grasping with left and right hand, fine manipulation right and left hand, pushing and pulling with left and righthand, reaching above and below shoulder level, use vision up close and distance, use vision color.

WORK ENVIRONMENT:

Typical Office Environment and occasional exposure to manufacturing and assembly environments.

TRAVEL REQUIREMENT:

• Occasional travel (typically less than 5%), including domestic travel by automobile or air.
• International travel may be required on an infrequent basis.

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.