Manufacturing Engineer

Description

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 Manufacturing Engineer I with a starting range of $108,000 - 121,000/year, dependent upon experience, education, and skills.  This position is eligible for a hybrid schedule of work from home and office.

The R&D Manufacturing Engineer I will develop and implement manufacturing processes for the building, testing, process improvement and delivery of Patient Specific Instrumentation and Implants.

Key Responsibilities

• Lead process development & sustaining efforts to direct functional engineering groups through process improvement and sustaining lifecycle including:
  • Improve the manufacturing process for Patient Specific Instrumentation and Implants (PSI) product lines.
  • Implement and improve Key Performance Indicators for the manufacturing process.
  • Identify, test, and implement process improvements for creating manufacturing Work Orders.
  • Identify, test, and implement process improvements for product kitting, packaging, and shipping.
  • Conduct root-cause investigations and initiate corrective actions for product non-conformances.
  • Support manufacturing design transfer for new product development.
  • Manage relationships and partnerships with existing suppliers.
  • Analyze potential new suppliers for strategic growth opportunities.
  • Conduct meetings as required to resolve issues, determine status, and provide information. Ensure adequate communication between engineers and other departments.
  • Ensure maintenance, safety, efficacy and compliance of existing product lines is maintained
  • Perform compliance related activities to ensure compliance with company and legal policies
  • Provide reports and presentations to management as required.

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 lab necessary, adhering to all lab safety requirements.

Travel

Up to 15% of overnight travel. 

Qualifications

• Requires a bachelor's degree of engineering in Mechanical Engineering, Biomedical Engineering or related engineering discipline.
• Minimum of 2 years direct experience in medical device field
• Demonstrated strong leadership style that motivates team performance by communicating a company vision and providing coaching to a team of engineers
• Experience in taking medical devices from ideation to commercialization required.
• Understanding of medical device industry regulatory requirements.
• Proven ability to plan and conduct effective meetings and group presentations.
• Proven ability and track record to handle multiple resources and priorities to meet key deadlines under pressure through effective time management skills.
• Proven track record of launching products; including timely delivery, critical thinking of project risk mitigation, cross-departmental driving, etc.
• Proven ability to lead, establish, maintain and influence effective working relationships with internal stakeholders across functional groups.
• Proficient with design control activities and verification and validation activities with respect to medical device development.
• Ability to navigate audits and FDA inspections
• Proven ability to critically review, interpret and approve technical documentation such as drawings, engineering specifications, protocols, reports, testing standards, regulatory guidance documents, safety rules, company policy and procedure manuals.
• Advanced problem solving and analytical ability.
• High proficiency in MS Office
• Effective communication and presentation skills with ability to clearly convey information and respond to questions from groups of peers verbally and in writing
• Proven 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.

Salary : $108,000 - $121,000