Senior Product Development Engineer I

Scorpion Therapeutics; Irvine (CA); Hybrid; USD 120,000 - 150,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Product Development Engineer I to lead the full lifecycle development of ENT medical devices from concept to market in Irvine, CA. You will design devices, prototype, and drive verification, validation, and usability studies while ensuring regulatory and quality compliance.

The role requires a strong background in medical device development, CAD proficiency (SolidWorks), and solid project management to coordinate cross-functional teams and vendors in a

Qualifications

• Bachelor’s in engineering.
• 4+ years in medical device development.
• Proficiency in CAD (SolidWorks).
• Strong project management.
• Experience with design controls.
• Risk management (ISO 14971).
• Relevant standards (ISO 13485, FDA QSR).

Responsibilities

• Design and develop ENT devices and accessories.
• Collaborate with vendors.
• Create prototypes and develop test protocols.
• Perform verification, validation, and usability studies.
• Incorporate VOC inputs.
• Lead technical reviews.
• Ensure regulatory and quality compliance.
• Communicate project status and risks.

Skills

Strong project management

Problem-solving skills

Experience with design controls

Risk management (ISO 14971)

Regulatory standards familiarity (ISO

Education

Bachelor’s in engineering

Mechanical Engineering degree (preferred)

Tools

CAD (SolidWorks)

Job description

Role

Senior Product Development Engineer I leading the full lifecycle development of ENT medical devices, from concept to market.

Responsibilities

• design and develop ENT devices and accessories
• collaborate with vendors
• create prototypes and develop test protocols
• perform verification, validation, and usability studies
• incorporate VOC inputs
• lead technical reviews
• ensure regulatory and quality compliance
• communicate project status and risks

Requirements

• Bachelor’s in engineering
• 4+ years in medical device development
• proficiency in CAD (SolidWorks)
• strong project management
• problem-solving skills
• experience with design controls
• risk management (ISO 14971)
• relevant standards (ISO 13485, FDA QSR)

Preferred

• Mechanical Engineering degree
• knowledge of statistical analysis (Minitab)
• process mapping (Visio)

High-Value

• Medical device sector
• ENT specialty
• regulated environment
• design for manufacturability
• cross-functional collaboration

Work setup

• Office
• remote
• or hybrid
• travel up to 25%