Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.
The Senior Manager will report to the VP of R&D and lead and manage a team of engineers, designers, and technicians to research, plan, and develop new products and systems. Directs and coordinates activities involved in design, fabrication, operation, application, installation, test, and repair of mechanical or electromechanical products and systems by performing the duties outlined below.
Responsibilities:
Manage technical professionals including engineers, designers and technicians, including recruiting, hiring, motivating and guiding them in their responsibilities.
Research and analyze data such as customer requests and specifications to determine feasibility of design.
Specify, design and document products or systems such as instruments and disposables, considering performance, patient safety, regulatory requirements, patents, and corporate goals.
Work closely with other departments to ensure projects conform to all regulatory and quality regulations.
Prototype designs using a variety of prototyping methodologies including additive manufacturing, RTV molds, machining, model making, gluing and painting.
Organize, plan, lead and manage team projects in alignment with project goals.
Aid in setting the strategy for the Product Development department.
Develop/improve manufacturing processes.
Stay up-to-date and follow all procedures related to this job that can affect the quality of products or services provided to our customers.
Qualifications:
BSME (MSME preferred) plus ten years experience designing electromechanical systems, and at least three years in medical devices.
Minimum five years experience designing using CAD, preferably proficient with Pro/E.
Proven track record of successful product development using a variety of design tools and prototyping techniques.
Proven track record of successful management of engineering professionals in a product development environment.
Working knowledge of project planning and management including use of PM software such as MS Project.
Ability to focus on and achieve scheduled milestones, including contingency planning.
Knowledge of FDA Quality System and Design Control requirements and their application to projects from design inception to manufacturing release.
Regulatory experience in 13485 current standard
Risk Management Technique and experience in ISO14971 current standard
Working experience with ESD environment
Strong team-working and communication skills.
A drive to get the job done in the face of obstacles and time constraints, and a willingness to assist as needed.
Competent using office software including MS Word, Excel, Internet Explorer and Outlook.
Demonstrated ability to multi-task.
Language and Verbal Skills
Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, specifications, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to clearly and concisely convey project accomplishments, obstacles, issues, and status to project team members.
Math Skills
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to use basic engineering tools to perform calculations and simulations and interpret project results/data.
Analytical and Reading Skills
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. Ability to read technical and clinical literature and documents and extract important concepts.
Physical Requirements
While performing the duties of this job, the employee may be required to perform lifting tasks of up to 30 pounds for short durations. The employee will be required to use a computer for up to 8 hours consecutively. Duties of this job may involve standing and/or walking for extended periods of time. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision and color vision.
Work Environment
The work environment is office and light manufacturing. Some light machining and prototyping activities will involve moderate noise levels (i.e. power drill) and moderate dust or debris exposure.
Safety
Solta is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.
The range of starting base pay for this role is 142K-214K. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.
Benefits package includes a comprehensive Medical (includes Prescription Drug), Dental, Vision, , Flexible Spending Accounts, 401(k) with matching company contribution, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts.
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We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.