Sr. Technical Program Manager

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 todays 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 Cirtecs 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 Cirtecs 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 50% may be required.

REQUIRED QUALIFICATIONS

A Bachelors 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 60601-1, 62304,60601-1-2, ISO

14708-1, 14708-3

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.