Lead Medical Device Engineer - Massachusetts
Pharma - Oncology - Cambridge, MA

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Lead Medical Device Engineer

Cambridge Massachusetts

Job Purpose


Lead and manage all project activities and apply scientific/technical expertise to address complex R&D issues and actively support Novartis Near- Patient Testing strategies and goals by participating in cross-functional teams. Interface with Strategic Marketing, technical functions and external contractors. L ead design and development of novel medical instrumentation systems in partnership with external engineering firms. Develop long-term strategies for Novartis Near- Patient Testing instrumentation technology.

Role Accountabilities

Technical Device Development Responsibilities
§ Provide technical leadership skill in all activities related to the development of the instrument system. Drive the evaluation and support the establishment of external device collaborations
§ Design, plan perform/supervise, monitor and contribute to projects related to complex scientific/technical engineering activities and design plan and supervise scientific experiments. Direct engineering activities across multiple stages of product lifecycle
§ Evaluate and implement new engineering/device technologies. Address complex research issues within own discipline and lead and supervise new device development activities.
§ Participate in creation of user and product device requirement specifications, FMEA, and hazard analysis. Lead risk analyses and/or peer review meetings
§ Report and present scientific work at internal / e xternal meetings /conferences and publish in peer-reviewed international scientific journals.
§ Implement new technical alternatives for research from literature review, industry knowledge, and experience
§ Ensure all own activities are aligned with international regulations and guidelines. Advise team members and work according to appropriate regulations and guidelines. Ensure compliance with regulatory re quirements. Ensure quality of international registration documents. Interact with authorities when appropriate.

Project Management Specific Activities


§ Manage relationships with outside engineering firms, device suppliers, component suppliers, and manufacturing partners
§ Proactively contribute to setting, updating and monitoring team goals. Create project plans and resource requirements to accomplish approved development programs. Translate team goals into daily work.
§ Inspire/coach/lead team members: support objective setting, performance evaluations, development planning discussions. Actively participate in the recruiting process. Develop, mentor and coach other team members. Support and assign associates in specific projects.

Stakeholder Management Activities

§ Proactively contribute to budget forecast and tracking of invoices. Ensure costs and cost-awareness in all assigned projects.
§ Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member
§ Interact/collaborate with other functions to facilitate transfer of knowledge.
§Develop, monitor and report on KPIs to enable strategic objectives to be met or corrective action to be taken

Performance Indicators

§ Accountability for costs, quality, quantity, and timelines for all assigned tasks.
§ Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards.
§ Feedback from other team members/leaders.
§ Refer to annual individual and team objective setting.
§ Outcome of risk analyses, technical review meetings, audits and inspections.
§ Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.
§ Internal and external publications/presentations, invited lectures.

Minimum requirements:

BS (minimum) MS or PhD (desired) in engineering.
Eight or more years (BS), or 5 or more years (MS or PhD) of i ndustry experience in engineering position for medical device design; experience in management of outside design and manufacturing firms, device suppliers, component suppliers; successful experience in cross-functional teams .

Novartis is an Equal Opportunity Employer.

Minimum requirements
Minimum requirements:

BS (minimum) MS or PhD (desired) in engineering.
Eight or more years (BS), or 5 or more years (MS or PhD) of industry experience in engineering position for medical device design; experience in management of outside design and manufacturing firms, device suppliers, component suppliers; successful experience in cross-functional teams.

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