Product Sustaining Engineer I (Packaging/Sterilization Team)

Paragon 28's growth continues and we're looking for more great employees! Now is your chance to join this public company dedicated to improving a patient's quality of life with the treatment of the most challenging foot and ankle conditions! We are currently looking to fill the position of Product Sustaining Engineer I with a starting range of $71,800 - $90,000/year, dependent upon experience, education, and skills. This position is eligible for a hybrid schedule of work from home and office.

The Product Sustaining Engineer (Packaging/Sterilization Team) has responsibility for leading projects that support legacy product systems and design and development of medical devices.

Key Responsibilities

• Produce deliverables pertaining to sustaining engineering activities for legacy product systems, as directed by senior engineering staff including:

• Update designs and device specifications for legacy products

• Conceptualize new design ideas for legacy product systems and new development projects or line extensions

• Use SolidWorks for parametric modeling and detailing designs of P28 products and packaging configurations

• Create or update design control documentation for P28 design history files & technical files.

• Create Engineering Change Requests (ECR) and manage through completion.

• Ownership of packaging/shipping related CAPAs. Participation in root cause analysis to investigate issues.

• Manage packaging projects from conception to launch, ensuring timely and efficient delivery

• Continuously evaluate and improve packaging processes and procedures to increase efficiency and reduce costs

• Keep up-to-date with industry trends and advancements in packaging technology

• Work closely with Marketing, Supply Chain and Creative Team to implement new designs

• Participate in activities related to project phase gate design reviews

• Manage relationships with external vendors and suppliers for packaging projects

• Other duties as directed by manager

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones and copy machines. Occasional use of the development and quality labs necessary, where lab safety must be adhered to.

Travel

10% of overnight travel.

Qualifications

• Requires a bachelor's degree in mechanical engineering, Biomedical Engineering or related engineering discipline with 2-5 years of experience.

• Prior experience in medical device devices sterilization methods (i.e., ethylene oxide, radiation, etc.) helpful

• Understanding of medical device industry regulatory requirements and standards preferred.

• Working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing Practices

• Working knowledge of validation of a packaging system for terminally sterilized medical devices as per requirements established by ISO 11607

• Working knowledge of SolidWorks or other packaging CAD programs (i.e., TOPS, SolidWorks, CREO, etc.).

• Proficiency in MS Office

• Effective communication and presentation skills with ability to convey information and respond to questions from groups of peers

• Ability to work in a team environment

P28 is a leader in the development and distribution of medical solutions for the foot and ankle industry. Established in 2010, every member of our inspired and dedicated team serves a vital role in the achievement of our mission: to strategically build a company around the core principles that drive innovation and quality. We're located at 14445 Grasslands Dr., just off E-470 and Peoria St. on the east side of Englewood, CO.

We offer comprehensive medical coverage with generously subsidized premiums for both employees only and coverage with dependents. Plans include prescription drug and behavioral health coverage as well as telemedicine services. Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness), pet insurance and more. Free counseling services and resources are offered for emotional, physical, and financial wellbeing through our Employee Assistance Program. A safe harbor 401(k) Plan with 3% match and an Employee Stock Purchase Plan, which allows purchase of P28 stock at a discounted rate. You are able to accrue 19 days of PTO over 12 months to maintain a fulfilling work/life balance. Our working environment is considered Colorado Casual. Onsite we have a fresh food kiosk, free parking and will have a new, expanded fitness center!

Paragon 28 is an equal opportunity employer and values diversity. All employment decisions are decided on the basis of qualifications, merit and business need.

Notice to Recruiters and Staffing Agencies: to protect the interests of all parties, Paragon 28, Inc. will not accept unsolicited resumes or referrals from any source other than directly from a candidate or an approved vendor that has a written and signed agreement in place through the Paragon 28, Inc. HR department. Please do not contact or forward resumes or referrals to our company employees. Any unsolicited resumes will be considered Paragon 28, Inc. property. Paragon 28, Inc. is not responsible for any charges or fees related to unsolicited resumes or referrals.