Medical Device Software Jobs in Indiana (NOW HIRING)

About Us

Intersurgical Inc. is a global leader in the fields of anesthesia, respiratory care, and medical device manufacturing. We partner with providers, manufacturers, and other organizations to supply innovative airway and medical devices that impact the lives of patients every day.

Driven by our commitment to supply high quality medical devices, our team works to deliver best in class products to over 60 countries worldwide.

Our Culture

We celebrate our culture of collaboration and communication. We believe in a workplace where everyone can be their full, authentic self.

We welcome and encourage those with diverse perspectives, veterans, and individuals with disabilities to join our team. We are an ambitious and innovative company and look forward to the unique experiences and different points of view you'll bring to the table while fostering a spirit of communication.

Job Overview:

The Engineering Project Coordinator plays a primary role in ensuring projects proceed according to required plans/constraints, as well as assisting with definition of project goals and scope, in collaboration with other project stakeholders, to achieve business and technical goals. The role also includes organizing and executing various tasks in the product development process.

Responsibilities:

• Collaborate with other project stakeholders to define project goals, scope, constraints, and scheduling
• Take ownership of project schedules and task completion, to ensure projects are completed according to specifications and within established timelines
• Communicate with project stakeholders throughout the project
• Collaborate across multiple departments to ensure the effective completion of all activities associated with Transfer to Production for an R&D project
• Collaborate across multiple departments to ensure the effective completion of all activities associated with maintenance of existing product lines
• Utilize a risk-based approach during the development, implementation, and validation of all processes
• Collaborate within the Engineering Department and across multiple departments to ensure product and design-related documentation is completed and kept up to date
• Assist with creating and updating process documentation (drawings, production instructions etc.) associated with new products
• Conduct and/or participate in internal audits
• Collaborate across multiple departments to create fixturing and displays as required
• Support efforts toward continuous improvement within the Engineering Department, including tracking key metrics and post-implementation reviews
• Work in collaborative and independent work situations and environments with minimal supervision

Education/Experience:

Bachelor’s degree in field related to engineering or project management preferred

Required or preferred certification:

Project management-related certification preferred, such as CAPM, CPMP, PMI-ACP, etc

Years of experience necessary for the role:

No experience required if bachelor’s degree in engineering or project management has been completed; if no degree, 2-3 years related experience preferred

Skills & Competencies:

• Excellent project management skills
• Attention to detail and strong organizational skills for managing multiple projects concurrently
• Ability to collaborate in a team focused on design, development, and implementation of new processes required for the manufacture of new device designs
• Excellent problem-solving skills
• Eligibility for international travel preferred

Technical or software proficiencies required:

• Proficiency in Microsoft Office products including Outlook, Excel, and Word
• Proficiency in Microsoft Project preferred
• Strong technical writing skills preferred
• Basic experience with SOLIDWORKS software preferred
• Experience with working in a medical device manufacturing environment preferred
• Experience with maintaining design and regulatory documentation for medical devices preferred, including device risk management and usability engineering
• Knowledge of medical device quality standards (e.g. ISO 13485) / FDA practices, MP, and similar regulated industry standards preferred
• Knowledge of statistics and process validation principles preferred

Soft skills beneficial to the role:

• Excellent people skills preferred, including with internal and external stakeholders

Physical demands:

• Must be able to speak, read, and write English
• Must be able to sit, stand, and/or walk for extended periods of time
• Must be able to lift 50 lbs.

Work conditions:

• Temperature-controlled facility with office and light manufacturing environment
• Non-smoking environment
• Safety hazards minimal with daily use of some chemicals
• Company-provided smock and hairnet mandatory in all controlled production areas
• Closed toe/heel shoes mandatory in all controlled production areas

Benefits:

We are passionate about the well-being of others and that begins with caring for our people.

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