Program Manager

Industry

Manufacturing and Production

Advert ID

FOX_BBBH50270

Location

Brooklyn Park

Job Type

Permanent

Hours

Full-Time

Salary Range

Up to USD100000.00 per year

No. of Openings

1

Branch Information

Milwaukee Engineering - (USA) 100 Manpower Place WI Milwaukee , WI 53212

ContactNumber

414-231-1150

Job Description

The Program Manager is primarily responsible for managing and coordinating development and manufacturing transfer of complex medical devices.



Responsibilities:





* Manages and coordinates development and manufacturing transfer of complex components, sub- assemblies and finished medical

* Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute activities based on well-defined

* Coordinates activities across different functional groups to ensure successful completion of program goals and

* Tracks program health in terms of schedule, budget, and technical risks and Prepares and presents comprehensive project status reports to internal and external stakeholders

* Proactively anticipates program 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

* Contributes to development, quality and risk management activities, and acts as backup to engineers and technical staff on assigned programs as required

* Serves as the principal contact with external Coordinates and directs customer meetings and visits, and day-to-day customer communication.

* Manages internal resources to meet program goals and Works with internal management to ensure appropriate resources have been assigned.

* Assists business development team with definition of program scope, timeline, and budget to support preparation of proposals, quotations, and change orders for customers

* Reliable, consistent and punctual attendance is an essential function of the job

* Other duties as assigned.



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.



Qualifications:





* Minimum BS in a relevant engineering discipline with at least 5 years of experience within the medical device industry

* Minimum 2 years of experience in project / program management of medical device development

* Experience with metals processing and Nitinol-based devices preferred but not required

* Demonstrated ability to lead medical device development projects from design through verification / validation, and transfer to production

* Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control

* Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents



* 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



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.