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Sr. Technical Program Manager

3 months ago

Minneapolis, Minnesota, United States Cirtec Medical Full time
Job Description

Job Description

This position is eligible for a $5,000 sign on bonus.
This position is located on-site based out of our corporate headquarters in Brooklyn Park, MN.

ABOUT THE COMPANY

Cirtec Medical is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities.

Cirtec Medical specializes in complex, difficult to produce components and devices in today's most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems.

We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers' devices to market.

If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you

JOB SUMMARY
The Senior Technical Program Manager will oversee all technical aspects of the Cirtec Medical SimpliFi platform product line. They must understand the market and customer base so they can make relevant technical decisions for product designs. This includes historical designs, present designs, and any future product expansions.

They must work effectively with design services, manufacturing, and regulatory groups to meet all technical requirements of the product line.


ESSENTIAL RESPONSIBILITIES

  • Must manage the catalog for Cirtec's platform devices and components
  • Lead the teams making technical design decisions
  • Manage pricing for components of the platform system
  • Learn the product line and be a technical resource for Business Development activities
  • Establish strategies for product improvements and new markets
  • Assist with product launches and marketing campaigns
  • Assist with the identification of potential customers for product offering
  • Attend industry meetings and trade shows to understand the market, present Cirtec's technologies, and develop strong customer relationships
  • Understand FDA and world regulatory body requirements for Class II and Class III medical devices
  • Comply with company, quality, and safety standards, policies, and procedures
  • Manages and coordinates development and manufacturing transfer of complex components, subassemblies and finished medical devices.
  • Generates and maintains detailed project plans, task lists and project risk registers that enable the
team to execute project activities based on well-defined prioritization.

  • Coordinates activities across different functional groups to ensure successful completion of project goals and milestones.
  • Tracks project health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders
  • Proactively anticipates project risks and issues, and carefully formulates and implements risk mitigations and
corrective/preventive

actions

  • Creates and maintains Design History file per internal company procedures, FDA Design Control (21
CFR 820) and ISO 13485 requirements

  • Supports project team in establishing and maintaining product requirements and test plans
  • Manages internal resource allocation to meet program goals and milestones.
  • Works with internal management to ensure appropriate resources have been assigned.
  • Reliable, consistent and punctual attendance is an essential function of the job
  • Other duties as assigned.
This is not a remote position.
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
Travel up to 25% may be required.

REQUIRED QUALIFICATIONS

  • A Bachelor's degree (STEM engineering discipline preferred) and 5 years of experience required; or a combination of education and relevant work experience.
  • Minimum 5 years of experience in project / program management of medical device development
  • Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820
based Quality Systems and Design Control

  • Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders
  • Must have proficiency in MS Project and other MS Office software
  • Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral
  • Willingness to travel, if required
  • 5 years of experience in medical device sales or product management

PREFERRED QUALIFICATIONS

  • Active implant experience
  • Experience in development of software, firmware and electrical for active implantable devices
  • Experience with the medical device IQ, OQ, PQ test stand progression
  • Knowledge of Agile development methodologies (Scrum, Kanban)
  • Familiarity with medical development standards such as IEC , 62304, , ISO
14708-1,

  • SysML, UML and MBSE knowledge
  • Knowledge of quality control principles and methodology

WHAT WE OFFER

In return, we offer you:
A fast-paced work environment
Paid time off
401(k) retirement savings with a company match
Clean, and well-lit production areas
Training and career development, with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

WORKING ENVIRONMENT
Work is performed in an office environment. The noise level in the work environment is usually moderate.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.


EEO STATEMENT
Cirtec Medical Corporation is an Equal Opportunity

Minority/Female/Individuals

with

Disabilities/Protected


Veteran and Affirmative Action Employer Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law.

Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

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