Senior Medical Device Engineer

Advanced Respiratory Technologies, Inc. is a medical device company located outside of Pittsburgh, PA that is developing a transformative artificial lung system for the treatment of chronic lung diseases. Our primary goals are: (1) to produce a means of permanent respiratory support for the hundreds of thousands of chronic lung disease patients who will not be able to receive a lung transplant and die each year and (2) Further develop our system to be utilized in treating and evacuating wounded soldiers from far-forward positions in close proximity to the battlefield to definitive care in the United States. Our company values and fosters a team based approach to accomplish these goals to transform the treatment of lung disease patients.

We are seeking a highly motivated and talented individual to join our team as an Senior Medical Device Engineer. As a key member of our Medical Devices team, you will be responsible for performing verification and validation (V&V) testing of medical devices; designing Class 2 medical devices and their injection molded components using 21CFR820.30 design controls; performing medical device risk analyses; designing components for manufacture; documenting all V&V activities for 510(k) submissions to the FDA; and interfacing with manufacturing consultants. In this position, you will collaborate with cross-functional teams to execute and deliver innovative engineering solutions that could help improve the respiratory health of people worldwide.

The ideal candidate has a passion for innovation, is detailed-oriented, and proactive in their approach.

Responsibilities

• Design and develop medical devices from concept through production release while adhering to design input requirements, project timelines, and quality standards,
• Interface with technicians to perform V&V testing of medical devices,
• Analyze V&V test data and prepare reports for FDA submissions,
• Perform medical device design within ART's quality system,
• Perform 21CFR820 risk assessments,
• Design plastic components for successful injection molding and ease of assembly,
• Interface with the Director of Regulatory Affairs to prepare design and testing documentation for FDA submissions,
• Participate in design reviews.
• Mentor early career stage engineers,
• Collaborate with cross-functional teams (e.g., product, manufacturing, quality, regulatory, clinical partners) throughout the product development process.

Typical workweeks are 37.5 hours with some increases in working hours as project timelines dictate. This position is fully on-site at our 1105 William Pitt Way, Pittsburgh, PA 15238 location. (Harmar Township)

Requirements

Key Requirements:

• Applicants must have earned at least a bachelors degree in Mechanical, Plastics, or Biomedical Engineering,
• 10+ years of prior experience in the respiratory and/or cardiac support medical device field, preferably working with blood contacting medical devices,
• 5+ years of prior experience performing V&V testing of medical devices
• High proficiency working within a medical device Quality System and in designing FDA Class II or III medical devices under 21CFR820.30 design controls,
• Prior experience performing risk management activities in compliance with FDA regulations,
• Excellent communication skills and ability to work in a team environment,
• Willing to work full-time on-site at our 1105 William Pitt Way, Pittsburgh, PA 15238 location (Harmar Township) or other ART locations.
• Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa.

Benefits

Benefits to working at Advanced Respiratory Technologies

• Be part of a growing team and medical device company that is developing new technologies that could each year treat hundreds of thousands of patients who have chronic lung diseases.
• A benefits package that includes:
• Medical, Prescription Drug, Dental, and Vision plan packages with significant company contributions
• Company Retirement contributions
• Paid Time Off
• Competitive Salary - $105,000-$135,000
• Earn Stock Options under a vesting schedule
• Flexible start time between 7 am and 9 am

When applying through workable you will be prompted with an optional survey to collect demographic data and for self-identification as a protected veteran and/or as an individual with disabilities.

Advanced Respiratory Technologies, Inc. is a Drug-Free Workplace.

Advanced Respiratory Technologies, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, age, marital status, family status, pregnancy, disease, genetic information, relationship to a person with a disability, and other categories protected by federal, state, or local law.

EEO is the Law

Applicants and employees are protected under Federal law from discrimination. To learn more, use the links below:

https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

https://www.eeoc.gov/poster

Pay Transparency Non-Discrimination Provision

Advanced Respiratory Technologies, Inc. follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, use the link below:

https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf