Hybrid Medical Device Development Engineer I

Lancesoft; Warsaw (IN); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Lancesoft in Warsaw, IN is seeking a Sr Development Engineer I to harmonize design controls and risk management for a new acquisition. The role supports integration activities, leads feasibility workstreams, and coordinates cross-functional teams to deliver product development projects.

The candidate will develop product and process specifications, identify critical-to-quality attributes, and prepare regulatory documentation while collaborating with global partners and leadership.

Qualifications

• Bachelor's degree in engineering with 3 years of relevant experience.
• ABET-accredited program in mechanical/biomedical engineering or related field.
• 3-5 years of experience in regulated medical device product development.

Responsibilities

• Harmonizes design controls and risk management with client processes.
• Lead feasibility workstreams and small projects for product development.
• Create project plans, timelines, budgets, and deliverables.
• Develop specifications and quality control strategies for infection-related performance.
• Prepare design control and regulatory documentation for approvals.
• Coordinate deliverables with cross-functional teams and external partners.
• Travel up to 25% for site collaboration.

Skills

Written communication

Verbal communication

Technical writing

Microsoft Office

Statistical analysis

Education

Bachelor's degree in Engineering

ABET-accredited program

Tools

Minitab

Job description

Lancesoft in Warsaw, IN is seeking a Sr Development Engineer I to harmonize design controls and risk management for a new acquisition. The role supports integration activities, leads feasibility workstreams, and coordinates cross-functional teams to deliver product development projects.

The candidate will develop product and process specifications, identify critical-to-quality attributes, and prepare regulatory documentation while collaborating with global partners and leadership.