Current Openings

This position is leading technical and cross-functional teams that are tasked with developing new, invasive medical devices. This role requires project management skills, personnel management skills and technical skills. The Group Leader will coordinate the activities of both technical and cross-functional teams involved in product development, and may be tasked with managing a small group of technical staff to accomplish goals and milestones. The Group Leader may be responsible for developing direct reports and ensuring their training is up to date. The Group Leader will be responsible for their group’s and team’s performance and their adherence to company procedures, FDA regulations, ISO regulations, and other applicable standards. The Group Leader will be most focused on tactical execution of project plans and goals. The Group Leader must have at least an introductory understanding of the entire business (manufacturing, finance, marketing, clinical, regulatory, etc.) to be effective. The Group Leader may occasionally be involved at various levels with strategic issues at a department level and / or corporate level, though their primary focus will be at the team level.

• 4-year degree, preferably in engineering. MS or MBA is preferred.

• Acts as project manager or team leader for medium to large project teams which require significant cross-functional involvement
• Provides daily direction and guidance to direct reports and team members
• Develops and manages project-level budgets with Manager oversight
• Escalates cross-functional support issues on projects to Project Review Committee and to Manager
• Presents project updates to Project Review Committee and oversees team compliance with approved Project Plans and schedules
• Manage the individual training of direct reports, including ensuring training records are up to date
• Ensures personnel and team members adhere to internal procedures and regulatory requirements
• Analyzes monthly project expense reports to budget, and manages project budgets
• Builds relationships with customers relating to their project(s)
• Provides guidance to the project team as a resource on internal design controls
• Provides direct, detailed guidance to project teams and creates/manages project schedules In MS Project/ProChain
• Responsible for individual project teams meeting milestones, and reporting project status and buffer consumption to Manager

The senior engineer will play the lead role on project teams in solving technical issues, developing and implementing test protocols, performing tolerance and material analysis, selecting and overseeing vendor activities, designing components, and providing technical decision-making and expertise. The senior engineer will be asked to lead cross-functional development teams in the design and development of medical devices.

• Experience required is eight plus years as an engineer in the related field. Masters degree preferred.

• Design and develop new products to support corporate goals.
• Assist in the creation and maintenance of project schedules.
• Work with cross functional teams to develop processes and documentation to support production of new products.
• Create test plans, protocols, reports and analyze data to support development of new products and processes.

The Marketing Communications Manager will manage the development and implementation of company and product line communications programs to support business objectives. Responsibilities include support of business and marketing leadership, product managers, and training staff in the development of product and corporate communications strategies and tools, managing corporate media relations and PR initiatives carried out by the company’s PR firm, management of the corporate website, and management of internal and external Marcomm resources.

• BS or BA in communications, journalism, information technology or related field. MBA preferred.
• 5+ years of marketing communications experience and previous leadership responsibility.

• Supports corporate and product line communications materials design, production, and distribution utilizing internal and external resources to ensure business objectives are met.
• Manages media relations function and PR support carried out by the company’s PR firm to achieve high business impact relative to resource utilization.
• Leads company’s public website activities including strategy, design, content, functionality, and traffic generation.
• Manages allocated marketing communications budgets to ensure business objectives are met with efficient and effective vendor solutions. Arranges vendor support for design, printing, multi-media, website, photography, duplication, etc.
• Works collaboratively with Promotional and Advertising Review Committee to ensure materials and initiatives are consistent in message/quality, within FDA guidance for Labeling and Advertising, and protects our corporate trademarks.
• Partner with Sales, Marketing, and Training directors and managers to ensure program objectives and deliverables are consistent with business objectives and marketing goals. Communicates directly with sales team to understand the sales environment and assess needs.
• Develops, motivates, and manages subordinates fulfilling Marcomm support roles.
• Supports convention preparations as appropriate.

Candidate must have outstanding written and verbal communication skills and strong working knowledge in communications including advertising, sales collateral, copy development/editing, website development, trade show execution, and audio/video presentation development. 
 
Candidate should be detail oriented with strong organizational and project management skills. 
 
Candidate should have demonstrated success in working with cross-functional teams and have strong understanding of pre-press requirements for high-end printing and other multi-media communications tools including digital files. 
 
Prefer production experience with sales materials for medical or high-tech marketplace. Prefer experience in a government-regulated and global marketing environment. 

To be the central communications link between a highly professional customer base and the Field Service team and to coordinate all aspects of company service calls on its equipment at customer locations worldwide.

• High School diploma and a minimum of one year experience working in a similar field.

• Serve as the initial contact for all customers’ worldwide requesting service support or technical documentation or other service related information in an organized and timely manor.
• Open calls in the Field Service Integrated System (FSIS) and provide the Field Service Engineers (FSE’s) with information on preventive maintenance or emergency or other assignments.
• Gathers the required information to process Product Complaints as required by company policy.
• Process Service Reports and enter data into the FSIS.
• Validates the accuracy of all data contained in completed service reports before closing a call in the FSIS.
• Works directly with FSE’s to obtain the necessary documentation to close all calls open within 20 days of the open call date.
• Updates customer contact and other information directly in the FSIS.
• Process return materials in Oracle.
• Generates and distributes information and reports as requested by management.
• Ensure complete customer satisfaction through monthly surveys.

Provide supports new product launches and provides sustaining support of manufacturing processes. This position is a lead technical engineer to provide process improvements and support for the manufacturing of disposable medical devices; demonstrating sound problem solving and design skills.

• Typical experience required is 8+ years as an Engineer in the related field.
• Four-year degree required, preferably in Engineering.
• An advance degree is preferred (MS or MBA).

• Lead technical engineers to provide processes improvements and support for the manufacturing of disposable medical devices; demonstrating sound problem solving and design skills.
• Assist with design for manufacturability in developing of new laser catheter medical devices.
• Assist a team in process development and improvements, solving technical issues, developing and executing validation protocols, and providing technical expertise.

Develops, establishes and maintains quality engineering methodologies, systems, and practices. Serves as a quality representative to improve awareness, visibility, and communication on quality initiatives. Provides focused quality engineering support within new product development. Maintains risk management documentation and provides quality engineering support for the life cycle of all products.

• BS in Mechanical Engineering, Biomedical Engineering, Process Engineering or related technical discipline.

• Provide QA leadership to project and system for the fill lifecycle of the product, service or system
• Develop, update and maintain SOPs, forms, methods related to Quality in the NPI/DC SOP and Risk Management system
• Ensure Risk Management is effective utilizing feedback from validation, field safety, manufacturing indicators, CAPAs, HHAs, ect.
• Lead and support Health Hazard Analysis to ensure risk assessment and root cause analysis across products and systems.

Strong and solid experience in Risk Management for medical devices 
Application and leading problem-solving, root cause analysis and related Corrective and Preventive Action (including verification) 
Experience with Health Hazard Analysis 
Familiarity with ISO 14971