Project Manager, NRO

Micro Systems Engineering, Inc.; Portland (OR); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Micro Systems Engineering, Inc. seeks a Project Manager to coordinate New Technology and New Product Development for medical devices, aligning with customer requirements and KPIs.

The role interfaces with senior and line management, suppliers, and international teams to deliver on time, within budgets, and in compliance with QMS and regulatory standards such as FDA MDR and ISO 13485.

Qualifications

• BS Degree in engineering in Electrical, Biomedical, Mechanical, or related discipline.
• Minimum 4 years’ experience in project management of medical devices or similarly regulated industry.
• Experience managing international/global development teams.
• Strong communication and leadership skills.
• Knowledge of FDA MDR and ISO 13485/21CFR820 recommended.

Responsibilities

• Coordinates international development teams to meet project/portfolio commitments.
• Develops and manages project plans, schedules, and budgets for NPD/technology projects.
• Maintains strong relationships with internal and external suppliers; identifies and selects suppliers.
• Interfaces with customers to ensure scope meets Voice-of-Customer needs.
• Provides updates to Senior Management and other departments; analyzes risks against budgets and timelines.
• Works with Design and Quality Assurance to ensure medical devices comply with QMS; may assist audits.
• Other duties may be assigned by the manager.

Skills

Strong communication skills

Leadership and team collaboration

Project management leadership

Global/international development

Regulatory knowledge (FDA MDR)

Education

BS Degree in engineering (Electrical, Biomedical, Mechanical, or related)

Job description

The Project Manager will coordinate New Technology and New Product Development efforts, consistent with medical device new product customer requirements. The Project Manager will interface with Senior Management, Line Management, and external customers and supplier to assure success against Key Performance Indicators.

PRIMARY JOB RESPONSIBILITIES

• Manages international development teams to assure technology and development efforts are achieved in alignment with established project and portfolio commitments.
• Develops and manages project plans, schedules, and budgets for NPD and technology projects.
• Develops and maintains strong relationship with internal and external suppliers. Lead the effort to identify, evaluate, and select relevant suppliers to meet project goals.
• Interacts with internal and external customers to assure scope of projects meet Voice-of-Customer needs.
• Provides regular updates to Senior Management, Product Management, Operations, and other departments to assure project deliverables are on track with intended goals. Using relevant KPIs, provides risk-based analysis of project to assure that project goals are met within constraints of given budgets and timelines.
• Works with Design and Quality assurance, leading the effort to assure medical devices are developed in compliance with relevant Quality Management Systems. May assist with product and QM audits, as necessary.
• Other duties may be assigned at the discretion of the manager.

REQUIRED QUALIFICATIONS

• BS Degree in engineering in the field of Electrical, Biomedical, Mechanical, or related engineering discipline.
• Minimum 4 years’ experience in project management of medical devices or similarly regulated industry.
• Experience in project management of international and global development teams.
• Demonstrated track record of technical project management leadership.
• Strong communication skills, with a focus on team collaboration/development.
• Strong group facilitation and mediation skills.
• Industry-related knowledge of medical device development.

PREFERRED QUALIFICATIONS

• PMP or similar certification.
• Familiarity with Agile and other project management methodologies.
• Direct knowledge of FDA and MDR regulations.
• Experience with ISO 13485 and/or 21CFR820 compliant Quality Management Systems.

LEADERSHIP RESPONSIBILITIES

• Work with MST customers as project liaison between the development team and stakeholders.
• Coordinate with team leads to drive project and establish estimates of project time and materials.

TRAVEL REQUIREMENTS

Must be able to travel internationally and domestically, less than 15% of the time.

WORK ENVIRONMENT

If onsite, this role is based in a temperature controlled professional office setting, which may include an office or cubicle with quiet to moderate noise level. If remote, the work environment is the employee’s residence. Work may need to be completed on campus in a lab, or manufacturing environment such as clean room or warehouse. Personal protective equipment is required in the clean room and may be needed in a lab. The noise level in the lab, and manufacturing environments are quiet to moderate. The role may travel to vendors, customers, external training, expos, industry or product events, and networking events shifting the work environment.

This position is Hybrid, based in out Lake Oswego, Oregon office.

ABOUT US

Working for Micro Systems Engineering, Inc. (MSEI) means joining an elite team to work on some of the most exciting challenges in medical technology today. We are a pioneer in developing innovative implantable medical device technologies and devices that save and enhance the quality of life for millions of individuals living with cardiovascular and chronic neurologic pain disorders. With more than 40 years of experience in design and manufacturing of active implantable medical devices, our continuing success is based on our company’s core values - innovation, quality, reliability, integrity, teamwork, and undisputed expertise - thus enabling us to inspire confidence and trust in physicians and patients worldwide. We are continually looking for talented engineers, scientists, and professionals to share in our mission.

Micro Systems Engineering, Inc. is an equal opportunity employer. In accordance with applicable law, the company prohibits discrimination based on race, color, religion, creed, gender, pregnancy or related medical conditions, age, national origin or ancestry, physical or mental disability, sexual orientation, genetic information, uniformed service or any other consideration protected by federal state and local laws. Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee.