"Alerted.org

Senior R&D Engineer Job Description

We are seeking an experienced Sr. Engineer to join our R&D, Sustaining team. The ideal candidate will work on the development and maintenance of peritoneal dialysis disposable sets, collaborating closely with project managers and technical leads to meet project goals. The role requires adherence to design control procedures and compliance with FDA and international regulations.

Responsibilities

+ Create new third-party supplier documentation including design specifications, labeling, and design drawings for peritoneal dialysis disposable sets.

+ Create, modify, and maintain design history files.

+ Perform change control assessments.

+ Collaborate closely with project managers and technical leads to achieve project commitments.

+ Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.

Essential Skills

+ Bachelor’s degree in Mechanical, Plastics, Biomedical Engineering or a related field; Master’s degree preferred.

+ 5 to 7 years of related experience in Class II or Class III disposables medical product.

+ Design for Six Sigma (DFSS) training or certification preferred.

Additional Skills & Qualifications

+ Experience working with external manufacturing partners and supplier relations.

+ Experience creating and modifying medical device design outputs including receiving and inspection criteria.

+ Experience in medical device product support and change control management.

+ Experience in design transfer from R&D to manufacturing.

+ Working knowledge of FDA Design Controls and ISO Quality Management Systems.

+ Working knowledge of ANSI/AAMI/ISO Medical Devices - Application of Risk Management to Medical Devices.

+ Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.

+ Strong collaboration, verbal and written communication skills.

+ Strong attention to detail, organized, and able to independently manage multiple priorities.

+ Ability to read, write and comprehend English.

Pay and Benefits

The pay range for this position is $30.00 - $30.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Minneapolis,MN.

Application Deadline

This position is anticipated to close on Aug 12, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.