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|Job Category :||Engineering|
|Company Name:||Paragon 28 Inc|
|Position Name:||Sr. Quality Design Engineer|
|Location :||14445 Grasslands Dr, Englewood, CO 80112|
|Job Description :||Paragon 28 is looking hiring a Sr. Quality Design Engineer with a starting range of $90,000-115,000/year, dependent upon experience, education and skills! This position is a full-time onsite role.We offer 100% employer-paid medical, dental and vision benefits for employee only coverage and generously subsidized premiums for coverage with dependents in addition to company paid life and disability benefits. Voluntary life/disability/accident options as well as flexible spending account plans are also available. We have a safe harbor 401(k) Plan with 3% match and PTO Plan allowing accrual of 19 days 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 fitness center!Located at 14445 Grasslands Dr., just off E-470 and Peoria St. on the east side of Englewood, CO, P28 is a leader in the development and distribution of medical solutions for the foot and ankle industry.Established in 2010, we are dedicated to creating industry leading solutions and tools to improve the treatment of the most challenging foot and ankle conditions. 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.Paragon 28 is an equal opportunity employer and values diversity. All employment decisions are decided on the basis of qualifications, merit and business need.Job TitleSr. Quality Design Engineer (231)Reports ToDirector of QualityJob OverviewThe Sr. Quality Design Engineer is a quality engineering position that has emphasis on developing and maintaining Paragon 28s quality system and related quality activities specifically relating to product development, manufacturing, and supply chain of Paragon 28 products.Essential Responsibilities and DutiesParticipating on project teams as a contributing member by providing quality engineering support in the development of new products and processes, and continuously improving company’s products.Writing and reviewing of procedures, plans, protocols and reports to ensure regulatory compliance.Develop acceptance criteria and measurement techniques for new product release.Perform Mechanical Inspections and use typical equipment used in inspection.Process Owner for Key Quality Processes; CAPA, Nonconformance, Internal Audit, Supplier Management, etc. applicable product linesLead Design Control and Transfer for release of new product development projects.Assists and/or leads in the development and execution of verification & validation plans, testing, and generation of test reports.Author and assist in the development and execution of process validationsPerform statistical analysis for testing requirements and develop MSAs and TMQs.Provide support for the manufacturing areas (internal and external). Work with production personnel and supervision to determine and monitor quality metrics, samples plans and address non-conforming product issues. Lead corrective and preventive action investigations to resolve the root cause of problems.Assisting project teams on compliance with design control requirements per FDA QSR, European MDD/MDR, ISO 13485 and other applicable ISO/EN standardsParticipate in risk management activities in compliance with ISO 14971 as expressed in the company’s Quality Management System.Participate in supplier qualification process. Interface with suppliers to ensure product compliance to specification and perform supplier audits as needed.Develop relationships with employees to ensure team-oriented operation.Accurately represents quality processes to 3rd party auditors (FDA, ISO 13485, MDSAP, etc.)Other duties as assignedWork EnvironmentThis job operates in a professional office environment, as well as being performed in a distribution/warehouse environment.Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.While performing the duties of this job, the employee is regularly required to communicate with individuals internal and external to the organization. The employee frequently is required to move about the facility. The employee may be required to lift up-to 15 lbs. by themselves.Position Type/Expected Hours of WorkThis is a full-time position with typical business hours. It may reasonably require additional hours during the week and weekend; specific requirements will be determined with Manager. Occasional remote work may be allowed.TravelTravel should not exceed 10% of total time. Supplier travel might be needed for on-site trouble shooting and or audits.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.QualificationsBachelor’s degree in Engineering or technical discipline4+ years in related field, preferably medical device.Familiarity with 21 CFR 820 and ISO 13485:2016 and other Government / ISO StandardsMedical Device Design ControlsTechnical writing skills that include Quality Management Systems (QMS) and proceduresProficient in Geometric Dimensioning and Tolerancing (GD&T)Verification and Validation experienceProficient in Machining methodologies (Titanium and Stainless-Steel experience best), knowledge of hardness, passivation, surface treatments, cleaning techniques etc. for communication with Suppliers and Engineers.MDSAP experience preferableBasic Computer Skills (MS Office)Job Type: Full-timePay: $90,000.00 – $115,000.00 per yearBenefits:401(k)Dental insuranceHealth insuranceLife insurancePaid time offVision insuranceSchedule:8 hour shiftDay shiftMonday to FridayEducation:Bachelor’s (Required)Work Location: One location|