Manager Of Medical Systems Development

IPG Medical, a wholly owned subsidiary of IPG Photonics (NASDAQ: IPGP), is focused on developing next-generation products based on IPG Medical's state-of-the-art laser technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.

Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged, diverse, and thriving workforce that drives a sustainable future for our company and society.

Working at IPG Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits.

The ideal candidate is a diligent, hardworking individual who is willing and able to learn new skills and technologies to ensure the IPG Medical team achieves its mission.

Job Function

• Develop product specification in coordination with marketing, customer and other company departments

• Manage and participate in product development from design input to verification and validation stage, following medical product quality system standards and regulations

• Coordinate technical part of transfer of company products and subsystems to customers or distributors

• Provide cost reduction program of medical products

• Assure products are designed to meet stringent global regulatory requirements of medical devices, such as FDA regulations, ISO 13485, CE mark for medical product and others

• Develop and maintain design history file and other documentation to support product regulatory approval and manufacture

• Plans and directly manages cross-functional projects that may include external resources and contracted companies.

• Formulates and gains approval for overall project plans in consultation with senior management and stakeholders.

• Proactively identify and assess areas of risk, escalate issues in a timely manner and proactively propose solutions.

• Partners with development team members to drive accountability and high quality of project tasks and deliverables. Continuous prioritization of team member activities and follow up on actions.

• Manages program budgets, generates forecasts, and tracks actuals against forecasts.

• 10+ years of work experience in research and development in light based medical products with more than 15 years in managing position of engineering resources of a company operated under ISO 13485 and FDA protocol in all phases from design input to transfer to production

• optical/electrical/mechanical/electronic lab experimentation with laser medical prototypes;

• coordination of laser, opto-mechanical; electrical and industrial design and embedded and application software of laser medical products, including main unit and delivery system

• rapid prototyping for pre-clinical and clinical studies

• Track record of executing complex multi-functional project on time and within budget.

• Ability to manage multiple projects in a fast-paced development environment.

• Proven experience working within controlled product development process.

• Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, EU MDR, ISO 14971, IEC 60601, 60825, and 62366, is preferred.

Education Requirements

• MS degree in an Engineering discipline or higher.

• Advanced skills in project management, projects reporting and presentations.

• Excellent written and verbal communication skills.

This position must meet Export Control compliance requirements, therefore a "US Person" as defined by 22C.F.R. §120.15 are required. "US Person" includes US Citizen, lawful permanent resident, refugee, asylee. License exception Technology and software under restriction (TSR) defined in 15 CFR 740.6 may permit person from Country Group B.

The following link will take you to the government site with the list of Country Group B: https://www.bis.doc.gov/index.php/documents/regulation-docs/452-supplement-no-1-to-part-740-country-groups/file

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