Product Development Engineer - AliMed Inc.

Our Company

AliMed is a leading medical products manufacturer and distributor with a vast portfolio of high-quality offerings designed to improve patient outcomes and experiences spanning hospital to home. We remain committed to serving the needs of both patients and providers in the acute, rehab, and post-acute care communities by continuing to build on our strong foundation of innovation, responsiveness, and exceptional customer service that starts with our team of dedicated and talented employees.

As a part of the healthcare industry for over 50 years, AliMed is proud to continue to be able to make a difference through our people, processes, and products. If you would like to be a part of our community and thrive in an environment where you can create, implement, and drive results, we want to hear from you! We are actively seeking a Product Development Engineer to join our team located in Dedham, MA.

Essential Duties and Responsibilities:

• Create accurate and complete specifications, drawings and work instructions in an FDA regulated environment.
• Ensure proper documentation.
• Practice DFM when creating and revising products and medical devices.
• Analyze and debug product issues and develop solutions to meet quality standards and to assure item availability.
• Collect failure data, analyze, report, take corrective action and drive continuous improvement throughout the product lifecycle.
• Create and enforce qualification standards across multiple product lines and functional departments.
• Solve problems of moderate scope and complexity following established policies and procedures.
• Perform root cause analysis on product field failures and drive assigned corrective actions to closure.
• Communicate and partner with vendors and teams worldwide to implement changes.
• Train/onboard new engineers.
• Purchase equipment or parts
  • Train others on the maintenance and use of new capital equipment.
  • Successfully streamline new equipment into product development processes.
• Review product designs for manufacturability or completeness.
• Design, build, evaluate and present prototype models and products.
• Design and develop products in various product lines, based on own ideas or input from other sources (colleagues, partners, industry etc.).
• Perform technical writing (Specifications, IFU, SOPs, DOPs, Work Instructions, any supporting information, Technical File).
• Prepare, complete, and execute a Technical File for EU submission.
• Identify deficiencies in current processes and determine next steps in getting issues addressed (continuous improvement of department framework and efficiency).
• Create and maintain test fixturing.
• Conduct and protocol testing.
• Analyze and present relevant statistical data derived from test protocols.
• Identify and mitigate potential risk during the development phase of product development.
• Communicate clearly and concisely with industry professionals during on-site visits or conferences.
• Lead meetings, thoroughly capture meeting notes to ensure accountability, project tracking, and accuracy of topics discussed.
• Translate clinical needs into detailed and measurable product specifications/design inputs.
• Develop ability to fully develop a new product from ideation to market with supporting documentation for all steps of process.
• Work cross-functionally, support other departments and "wear multiple hats" as needed.
• Begin process of shifting department/company from Class 1 devices to Class 2 and audit prep (documentation, framework, backfilling).
• Assist with other responsibilities and tasks as needed.

Education and/or Work Experience Requirements:

• Bachelor's degree in Mechanical Engineering.
• 5+ years of experience in medical devices industry, ISO 13485 environment.
• CAD experience (SolidWorks).
• Knowledge of manufacturing engineering technologies and assembly techniques.
• Knowledge of basic machining, plastic fabrication and measurement techniques.
• Experience with textiles is a plus.
• Desire to be the "go to" person when issues arise with inside and outside suppliers.
• Must have the desire to learn new skills.
• Ability to drive results quickly and completely with attention to detail.
• Demonstrate ability to work mostly independently, with minimal supervision.
• Great sense of responsibility, urgency, enthusiasm and high energy.

Physical Requirements:

• Ability to safely and successfully perform the essential job functions consistent with federal, state and local standards, including meeting qualitative and/or quantitative standards.
• Ability to maintain regular, punctual attendance.
• Must be able to lift and carry up to >20 lbs.
• Must be able to talk, listen and speak clearly.