Sr Product Development Engineer

LightningCath Inc; Brooklyn Park (MN); In loco; USD 105.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

401(k) Plan with company match

Paid Time Off

Paid Holidays

Descrizione del lavoro

LightningCath Inc. is seeking a Sr Product Development Engineer to lead design, development, implementation, and analysis of technical medical devices and systems.

You will work with project managers and customers on plans, schedules, budgets, and execution of complex engineering tasks to enable compliant product delivery. Responsibilities include design, prototyping, documentation, and collaboration across teams to ensure manufacturability and quality while meeting regulatory standards.

Competenze

• 5+ years of engineering experience, preferably in the medical device industry.
• Bachelor's degree in mechanical, biomedical or chemical engineering, or equivalent experience.
• Hands-on experience with QSR CFR 820, ISO 13485 and ISO 14971.

Mansioni

• Develop detailed project plans, schedules, and budgets with project managers and customers.
• Design, develop, and prototype devices and processes to meet customer needs and quality goals.
• Involved in building and shipping products; provide technical guidance to technicians.
• Create and maintain manufacturing procedures, work instructions, protocols, and reports to ensure regulatory compliance.
• Collaborate with customers to meet deliverables and timelines; support new product introductions.
• Assist in estimating costs and project timelines for bids and budgets.

Conoscenze

Project management

Mechanical design

Regulatory awareness

Formazione

Bachelor's degree in mechanical/biomedical/chemical engineering

Equivalent experience considered

Strumenti

QSR CFR 820

ISO 13485

ISO 14971

Descrizione del lavoro

Description

Summary

The Sr Product Development Engineer executes in design, development, implementation, and analysis of technical products and systems. Works directly with project managers and customers managing projects, and performs simple, routine, and complex engineering design tasks with standard techniques. This role facilitates functional product development and operations engineering efforts.

Essential Duties and Responsibilities (but are not limited to)

• Partners with customers and project managers to develop detailed project plans, schedules, and budgets to effectively manage resources and timelines.
• Design, development, and prototyping of new devices, components and processes to meet the customer needs, lower costs and improve the quality of the product.
• Directly involved with the building and shipping of products.
• Provides technical guidance and work direction to technicians.
• Establishes new and/or improved processes based on product and design criteria.
• Evaluates process and design alternatives for manufacturability and clearly communicates yield and throughput assumptions.
• Works within the team environment to solve quality and design issues and transfer processes to manufacturing.
• Creates, maintains, and updates technical documentation, such as manufacturing procedures, work instructions, protocols, and reports, ensuring compliance with regulatory requirements.
• Maintains knowledge of new developments in manufacturing and design technologies.
• Works with customers to meet their deliverables and timelines.
• Takes part in business development process, especially with new and existing customer new product introduction.
• Aids in establishing costs basis and timeline estimates for projects and ongoing financial activity such as pre-invoicing or budget tracking.

Requirements

Education/Experience

5+ years of experience in engineering, preferably in the medical device industry.

Bachelor’s degree in mechanical, biomedical or chemical engineering. Equivalent combination of education and experience may be considered.

Hands-on experience and strong knowledge of QSR CFR 820, ISO 13485, ISO 14971 and other relevant standards.

Summary of Benefits

• Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan).
• Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Short Term Disability (STD).
• 401(k) Plan with company match
• Paid Time Off
• Paid Parental Leave
• Paid Holidays
• Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.

Compensation

• The typical base pay range for this role is between $105,000-130,000/year. Actual compensation will be based on individual job-related knowledge, skills, expertise, and experience.