Engineering Project Manager - Medical Devices

Arthrex GmbH; Santa Barbara (CA); Hybrid; USD 92,000 - 167,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Matching 401(k) retirement plan

Annual bonus

Tuition reimbursement

Job summary

Arthrex, a global leader in orthopedic medical devices, is seeking an Engineering Project Manager in Santa Barbara, CA to lead cross-functional development programs from concept to commercialization.

Collaborating with engineering, manufacturing, quality, regulatory, and business teams, you will deliver service-ready medical technologies on time, within budget, and in compliance with industry standards.

BS Engineering and 2 years of relevant experience required.

Qualifications

• Bachelor's degree in engineering required.
• Minimum 2 years of relevant experience.
• Knowledge of medical device regulations and quality systems.
• Experience with new product development processes.

Responsibilities

• Manage global projects within the scope of new product development.
• Set project objectives with stakeholders and senior management.
• Define schedules and allocate resources.
• Monitor progress and mitigate risks.
• Ensure design history file and design controls compliance.
• Maintain project scope and manage changes.
• Collaborate across functional teams to drive milestones.

Skills

Project management

Cross-functional collaboration

Communication skills

Problem solving

Regulatory awareness

Risk management

Attention to detail

Education

BS Engineering

Biomedical/Electrical/Mechanical preferred

Job description

Manufacturing - Santa Barbara, CA, US, 93111

Engineering Project Manager - Medical Devices

Title: Engineering Project Manager - Medical Devices

Salary Range: Salary Minimum: $92,000.00 Salary Maximum: $167,000.00

Are you an engineer who enjoys bringing innovative ideas to life while leading teams through complex development challenges? At Arthrex, a global leader in orthopedic medical devices and medical education, we're seeking an Engineering Project Manager within the Global Service and Repair Organization to support cross-functional new product development programs from concept through commercialization. In this role, you'll partner with engineering, manufacturing, quality, regulatory, and business stakeholders to deliver life-changing, service ready medical technologies on time, within budget, and in compliance with industry regulations. If you're a collaborative problem solver who thrives in a fast-paced environment and wants to make a meaningful impact on patient care, you'll find a rewarding career at Arthrex, where our mission is Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Manages subsidiary-based and global projects/programs within the scope of the new product development
• Develop project objectives by reviewing project proposals and business plans, conferring with senior management and key stakeholders
• Determines project schedule by studying project plan and specifications, calculates time requirements, identifying and sequencing project elements and discreet tasks
• Maintains project schedule by monitoring project progress, coordinating activities, and resolving risks or obstacles
• Determines project responsibilities by identifying project phases and elements, requesting and allocating resources as necessary
• Ensure design history file facilitation for assigned projects, adhering to Arthrex design control procedures.
• Ensure project progresses within the boundaries of the approved scope. Manage the scope of the project and guarantee scope changes are properly documented and implemented.
• Identify opportunities for improvement within the Project Management Governance and Design Control Process to improve speed to market.
• Monitor resource capacity within the New Product Development groups and cross-functional resources and communicate constraints or needs to senior management.
• Help facilitate, with interdepartmental managers, the availability, assignment, and accountability of downstream resources and technology
• Help facilitate project, program and portfolio status to management and key stakeholders with applicable metrics and project constraints.

Knowledge:

• Limited use and/or application of basic principles, theories, and concepts. Limited knowledge of industry practices and standards.

Reasoning Ability:

• Solves routine problems of limited scope and complexity following established policies and procedures.

Skills:

• Ability to effectively communicate project planning requirements, including task elucidation, duration, and resource requirements.
• Strong strategic thinker, excellent collaboration and communication skills, careful attention to detail.
• Ability to balance business and technical Ability to effectively communicate project planning requirements, including task elucidation, duration, and resource requirements.
• Strong strategic thinker, excellent collaboration and communication skills, careful attention to detail.
• Ability to balance business and technical risks while remaining compliant with internal systems.
• Awareness of full life cycle development of medical devices, which includes initiation, design, development, execution, and sustaining.
• Working knowledge of medical device regulations and associated quality systems, particularly design controls and risk management.
• Manufacturing process knowledge preferred.
• Awareness orthopedic surgery principles, theories, and products preferred.
• Knowledgeable of FDA and ISO guidelines for the development of medical devices preferred.
• Strong communication skills and accountability to project deliverable timing and budgets required.
• Ability to confidently lead complex, cross functional teams independently.
• Strong desire and proven ability to learn quickly.
• Continuously seeking ways to improve complex systems of people and processes, while eliminating waste.

Education/Experience:

• BS Engineering required. Biomedical, Electrical, or Mechanical preferred
• 2 Years of Relevant Experience

Reasoning Ability:

• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills:

• Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Time Off
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.