Vp Of Medical Devices Jobs

Lead the design, development, and optimization of novel neuromodulation products, ensuring compliance with regulatory requirements and industry standards.

Manage the R&D budget, allocate resources effectively, and provide regular updates to executive leadership on project status, risks, and opportunities.

Deep knowledge of neuromodulation technologies, including implantable devices, stimulation techniques, and related therapeutic applications.

Excellent leadership, communication, and interpersonal skills, with the ability to effectively collaborate with multidisciplinary teams and influence key stakeholders.

Foster a culture of innovation and collaboration within the R&D department, promoting continuous learning and development of team members.

Advanced degree (Ph.D., M.D., or equivalent) in a relevant scientific or engineering discipline.

Manage the supplier/vendor qualification program and Approved Supplier/Vendor List, including Quality Agreements with contractors, suppliers and vendors

Ability to prioritize and manage to critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently

Partner with R&D on EMC and safety (UL/CSA) certification

Lead and Manage activities for receiving inspection, device history records, component release and process validation

Lead, manage, and approve DMR, DHR, and Validation Protocols and Reports related to processes, equipment, facility and computer systems

Manage the equipment calibration program

Collect, manage, analyze, and interpret complex scientific data from multiple sources to support technology development and clinical validation.

Knowledge of medical devices, genomics, molecular biology, or microbiology

Experience with programming languages such as Python or R

Strong analytical and problem-solving skills

Excellent communication skills and ability to present findings to non-technical stakeholders

Experience working in the cloud

3+ years of front-end technologist, engineer, or UX prototyper experience

Experience with UI design for complex workflows and for end users

Bachelor's degree in a related field or equivalent professional experience

Experience designing 3D spatial interactions for AR/VR or games using tools like Unity, Unreal Engine, etc.

Experience prototyping with novel sensing and display technologies.

Experience applying machine learning (ML) tools and methods.

Work with designers, product managers, management, internal business partners and other subject matter experts

6+ years of front-end technologist, engineer, or UX prototyper experience

Experience developing visually polished, engaging, and highly fluid UX prototypes

Experience collaborating with UX, Product, and technical partners

Knowledge of databases and AWS database services: ElasticSearch, Redshift, DynamoDB

Experience with machine learning (ML) tools and methods

Experience with Product and Process Validations: IQ, PQ, OQ

Experience lead root cause investigations

Experience tracking and recording KPI data

Experience communicating with other departments and working Cross functionally

Industry Leader in Medical Device|Flexible Work Environment & 15% Bonus

Oversee Quality deparment of 20, including 6 direct reports

Technical background or degree in Science or Business, with proven testing, consultation, and time management skills.

Manage and oversight of engineering team conducting tests, including lab efficiencies, and upgrade accreditation scopes.

Knowledge of medical product safety standards (IEC/UL 60601 series including 60601-1).

7-10+ years of experience in Medical Device testing.

A motivational team player, with a positive "can-do" attitude who proactively manages conflict and positively engages with colleagues.

Annual Bonus/ Team Lead modifiers up to 2.5x

BS in Engineering, Supply Chain, Manufacturing Management, Business or related field

Minimum of 10 years of progressive manufacturing or supply chain leadership experience

15 years of total manufacturing experience

MUST HAVE MEDICAL DEVICE EXPERIENCE

Oversee manufacturing activities to ensure maximum effectiveness is obtained to produce & assemble quality products within specified time & guidelines

View Operations through an entrepreneurial lens approaching it as a profit center versus a cost center

MS Office skills (Word, Excel, Outlook), iOS/OS skills, and internet skills; database and CRM experience.

5 years sales experience required; in a medical device industry preferred

1-3 years capital equipment sales experience required

Respiratory therapy, Nurse, clinical lab or similar work experience helpful.

The essential requirements of the job include:

It would be a plus if you also possess previous experience in:

Knowledge and application of cGMP requirements, Device and Combination Product requirements, in major pharmaceutical markets (USFDA, EMA..)

Strong technical and scientific skills with proven experience in the development of packaging solutions for parenteral and/or Inhalation products.

Lean Six Sigma Green Belt or higher certification with strong problem solving skills

Strong experience with medical device or combination product commercialization, operations support, and materials/components.

Demonstrated ability to simultaneously manage multiple projects of variable complexity.

Experience of leading cross disciplinary delivery teams

Experience with Systems Engineering and requirements management.

DFSS knowledge and experience or statistical test design and analysis knowledge or Critical Parameter Management.

Familiar with systems integration and testing, system architectural planning and design, Reliability Engineering, Project Management, and Failure Modes Effects Analysis.

Facilitates cross-functional knowledge and experiences to promote the understanding and resolution of in-market and product development issues

Work experience required (combination of work experience and advanced degrees).

Working knowledge of product development lifecycle

Work closely with corporate contract management and legal staff to ensure all contracts meet internal management and legal requirements.

At least 5+ years of related work/sales and 2+ years of sales management experience required.

Proven track record of sales success with particular focus on negotiation skills, ASP management and revenue and market share enhancement.

Partner and assist all sales team counterparts in the development, implementation and management of strategic initiatives within targeted accounts and geography.

Prior experience and knowledge of the medical devices strongly preferred.

Experience in growth and mature businesses as well as multiple product portfolios a must.

Master's degree or Project Management Certificate

Knowledge or experience within the healthcare industry and GE Healthcare products

Proficient in Project Management Software such as Workbench, MS Project, Smartsheets, or similar tools

Six Sigma certification and/or experience in Lean methodology

Demonstrated customer service experience working in a clinical environment

Act as team lead and assist with hiring and establishing team processes

Mediates employee/management complaints or disputes.

MINIMUM EDUCATION AND EXPERIENCE REQUIRED:

Creates and/or reviews are written communications to employees and provide educational programs.

Sets budget guidelines to assist Human Resources managers in preparing well-planned, cost-efficient budgets.

Advises and counsels entity leadership, administrative staff, managers, and/or employees on complex human resource issues.

Experience in a hospital environment is highly preferred

·Influence exerted at peer level and occasionally at first levels of management.

·Provides guidance to less experienced staff.

·Related work experience with a good understanding of specified functional area.

·Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function.

·Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

Hope you are doing well,

Does the position allow for the worker to be virtual/remote? : No

Shore Options Available for this Position : Onshore Only

Direct or Indirect : Indirect

• Strong project management, planning and organization skills; PMP training

• Manage projects for the customer's development process and desired design

supplier changes, remediation, and recertification.

• Manage creation of engineering drawings and solid models in SolidWorks 3D.

projects from concept to commercialization, with knowledge of FDA Class II

• Experience developing metal medical devices such as needles, surgical

Demonstrate deep Medical Device knowledge;

Manage and retire an 8-figure sales quota annually;

Generate a growing list of opportunities through network;

Provide Prospective Clients with critical strategic thinking about their business;

10+ years working directly with C-Suite decision makers in the Medical Devices industry;

Multi-year track record of goal attainment in a consultancy or agency;

Participating in risk management activities and assisting in the development of risk management plans.

Developing, implementing, and maintaining quality assurance programs that meet regulatory requirements and customer expectations.

Break Into Medical Device Industry Within This Role|Great Total Package

Conducting audits and inspections to ensure compliance with FDA regulations and ISO standards.

Developing and executing quality control plans, including incoming inspection, in-process inspection, and final inspection.

Investigating and resolving customer complaints related to product quality.