Product Development Engineer

hace 3 semanas

Lima, Perú Enovis A tiempo completo

Job Description:
At Enovis we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence — with the goal of transforming medical technology as we know it. Because that’s how we change the lives of patients for the better. And that’s how we create better together.

As a key member of the Surgical R&D Team you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

Location:
ProMade PoC Center, NY

Business Unit Description:
Driven by Enovis’ desire to create innovative products that help improve quality of life and restore movement to those suffering from degenerative arthritis, Enovis Surgical® provides orthopedic surgeons with modern, patient-focused solutions for total joint arthroplasty. Partnerships with key surgeon consultants help provide advanced and proprietary patented solutions, including EMPOWR 3D Knee®, the only dual-pivot knee system on the market, and AltiVate reverse® Shoulder, a market-leading system, based on the design principles of the RSP® Shoulder, which has demonstrated excellent clinical outcomes at 10 years.

Enovis Surgical offers surgeons and their patients a full range of primary and revision implants for hip, knee, shoulder, and elbow reconstructive joint surgeries, in addition to the tools and digital health technology needed in today’s changing healthcare environment.

Job Title/High Level Position Summary:
Manages a specific product or group of products from product definition and planning through production and release. Responsible for coordinating employee recruitment, selection and training, performance assessment, work assignments, salary, and recognition/disciplinary actions. Directs interfaces with central resource in design, process, manufacturing, test, quality, and marketing as the product(s) move to completion and distribution. Manages production support engineering with respect to testing methods, procedures, and problems; device specification and yield problems; redesign of devices; analysis of customer returns; and optimization of device production relative to cost constraints. Serves as adviser to sales force and customers on all matters concerned with designated products. Recommends product program development and/or enhancements as a result of customer and/or sales force feedback.

Key Responsibilities:

- Design and technical management of custom cases with the support of Product Development team.
- Develop and manage needed documentation for the development and registration of Custom implantable components and instruments.
- Evaluation and responsibility of congruency of design Inputs.
- Actively discuss case design with surgeons and sales reps, critically evaluating components design inputs.
- Autonomously provide surgical field support for custom made products.
- Proactively communicate in within Company Functions for the respect of designed products timelines, costs and quality standard.
- Proactively evaluate possible design flow implementation.
- Participate at meetings with KOL/internal and external stakeholders to collect Base Business project requirements and to contribute in preparing results presentation based on work progress.
- Analyzing Base Business project requirements and their translation into project inputs, validation, and verification requirements (IOVV).
- Responsible for ensuring the feasibility of the design and for interaction with manufacturing to transform prototypes into production and to find solutions to potential problems during manufacturing or controlling and proactively thinking in design for manufacturing concept.
- Responsible for the definition of technical specifications, work instructions, standard operating procedures (SOP), test plans, testing protocols (worst case analysis, FEM analysis), critical analysis of test reports, tolerance analysis, verification protocols for instruments sets, design change modules and implant ROM.
- Understanding of basic biomechanical principles and basic maneuvers in the operating theater.
- Responsible for creating the required technical documentation that is required for certification renewals and geographical expansion (product registration in other Countries rather than the ones included in NPD process.
- Other duties as required.

Minimum Basic Qualifications:
Bachelor’s degree from an accredited college in a related discipline, or equivalent experience/combined education, with 2 years of professional experience; or no experience required with a related Masters degree. Considered experienced, but still a learner. Medical Device industry required

Travel Requirements:

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