Role Summary

The Development Engineer moves released designs from R&D into production. They make sure design outputs are complete, manufacturable, and verified as suitable for manufacturing, and that Operations and suppliers can build the product to specification. They partner with design engineers early, before design freeze, to give manufacturability input, and they own the transfer documentation package through completion. As project needs arise, the role also contributes to earlier-phase work, including requirements, design, and verification testing.

Key Responsibilities

Design Transfer Execution

• Lead design transfer for assigned projects, including creating and maintaining transfer plans, checklists, and transfer reports.

• Confirm design outputs (drawings, BOMs, specifications, work instructions, inspection and test methods) are complete and suitable for manufacturing before they become production specifications.

• Coordinate handoffs to Operations, Quality, Supply Chain, and external suppliers, and close open transfer items.

• Support pilot and first production builds, documenting issues and driving them to resolution.

Manufacturability (DFM) Contribution

• Participate in design reviews and provide independent DFM/DFA feedback on design inputs and outputs, before freeze where possible.

• Identify manufacturability, tolerance, and assembly risks and raise them with design owners.

• Support the development of manufacturing work instructions, fixtures, and test methods.

Validation and Documentation Support

• Author and execute process validation (IQ/OQ/PQ) and test method validation protocols and reports, or support them where Operations or Quality holds ownership.

• Author and review transfer-related documentation in the design history file and device master record.

• Initiate and support engineering change orders that arise during transfer.

• Contribute to risk management files (e.g., process FMEA inputs) for transferred designs.

Early-Phase Project Support

• Contribute to user needs, design input, and requirements definition, with emphasis on making requirements testable and manufacturable.

• Support design activities such as concept evaluation, tolerance analysis, and design output development for assigned components or subsystems.

• Develop and execute design verification test protocols and reports, including test method development and fixture design.

• Maintain traceability between requirements, design outputs, and verification evidence in the design history file.

• Participate in design reviews and risk management activities (e.g., design FMEA inputs) for assigned projects.

Team and Compliance

• Work within the quality management system and follow design control and documentation practices.

• Communicate status, risks, and schedule impacts to the Manager, Systems Engineering and project teams.

Required Qualifications

• BS in Mechanical, Biomedical, Manufacturing, or a related engineering field.

• 3–7 years of engineering experience in medical devices or another regulated industry, including hands-on ownership of design transfer, NPI, manufacturing engineering, or process development activities.

• Working knowledge of design controls and quality system requirements (ISO 13485, FDA QMSR).

• Experience with engineering drawings, GD&T, BOMs, and change control.

• Familiarity with process or test method validation concepts.

• Experience writing and executing verification or validation test protocols, and familiarity with requirements management and traceability.

• Clear written communication and the ability to manage several workstreams.

Preferred Qualifications

• Experience with electromechanical or disposable single-use medical devices.

• Experience with supplier development or supplier-built components.

• Working knowledge of risk management (ISO 14971) and statistical methods for validation.

• CAD, PLM, and eQMS experience.